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.
Bd has
received multiple reports of units associated with the 23 g x .75 in. bd vacutainer¿ push button blood
collection set with 12 in. tubing whose lots are exhibiting separation of
front and rear barrels upon activation of the safety feature, which retracts the
needle.
Acción
The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com.
if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.
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.