U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pin, fixation, smooth - Product Code HTY
Causa
The g-pin 2.8bl 3.2pl 60 cm 2pk is intended to contain one (1) 467265-01 ball tip guide pin and one (1) 467255-02 plain tip guide pin. the g-pin 2.8bl 3.2pl 60 cm 2pk may have been packaged incorrectly either with two (2) 467265-01 ball tip guide pins and zero (0) 467255-02 plain tip guide pins or with zero (0) 467265-01 ball tip guide pins and two (2) 467255-02 plain tip guide pins.
if the g-pin 2.8bl 3.2pl 60 cm 2pk contains the incorrect combination of plain tip guide pins and ball tip guide pins, the surgeon would either have to implant the nail without the plain tip guide pin as a guide, ream with a plain tip guide pin, or choose to not ream the humeral canal. the risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
Acción
The firm, Zimmer Biomet, sent an " URGENT MEDICAL DEVICE RECALL REMOVAL" notification dated 8/2/2016 affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The consignees were instructed to review the notification and ensure affected team members are aware of the contents; immediately locate and quarantine affected product in your inventory; complete and return the Certification of Acknowledgment portion of Attachment-1 Inventory Return Certification Form via digital copy within three (3) days via email to CPWARFieldAction@zimmerbiomet.com or via fax to 574-372-1683;
Immediately return all affected product from your distributorship and affected hospitals within your territory; and retain a copy of your recall acknowledgement and product return form.
If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Guide, surgical, instrument - Product Code FZX
Causa
Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. the old revision tissue sleeve has too much clearance with new revision targeting arm.
risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another recon targeting arm or recon soft tissue sleeve is located or while the surgeon completes the procedure by hand.
Acción
On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
For questions or concerns call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. the old revision tissue sleeve has too much clearance with new revision targeting arm.
risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another recon targeting arm or recon soft tissue sleeve is located or while the surgeon completes the procedure by hand.
Acción
On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
For questions or concerns call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The drill bit used to drill the hex pre-drilled hole in the screw head of the tibial augment bolts included in the vanguard 360 revision knee system was larger than allowable per the process specification. as a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened.
the bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. this possible event can result in an intraoperative delay resulting in increased time under anesthesia.
Acción
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL notifications dated August 8, 2016, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For further questions, please call (800) 348-2759.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Contents of the package do not match the product labeling.
product is labeled: vanguard distal femoral augment 75 x 5 rl/lm
carton contains: vanguard distal femoral augment 75 x 5 ll/rm
risks:
adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure.
as the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
Acción
On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a call back the next business day. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.