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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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.
Perfusion ct is displaying a higher gray and color values than normal. a software problem.
Acción
Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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 better bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. seal separation from the housing may allow air to enter the housing and collapse the balloon. this may increase resistance to flow in the venous line and cause a drop in ecmo circuit blood flow.
Acción
Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication.
End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by contacting Customer Service at 1(888) 627-8383 (option 2, then option 2 again), Monday through Friday, 8AM-6PM. In addition, customers were asked to complete a response form to acknowledge receipt of the notification, and return to Getinge.
After communications with some end-users who were concerned about maintaining inventory of custom tubing kits, Getinge revised their recall strategy to include an option for replacement of the recalled Better Bladder device. Customers who wished to receive a replacement device will be provided with the device and a notice which must be affixed to the recalled kit. This will ensure that at time of use, it will be obvious to the user that the Better Bladder device inside the kit must be switched out with the replacement device prior to use. The removed recalled Better Bladder device must then be sent back to the recalling firm, Getinge. This information was communicated to customers via telephone call or visit on 4/20/18, and a summary of the communication was sent as an amended recall notification to customers who stated during the phone call that they still had recalled product on 4/21/18.
Maquet/Getinge Customer support may be reached at 1(888) 627-8383 (press option 2, then option 2), Monday through Friday, 8AM-6PM.
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
Dental Device, anti-snoring - Product Code LRK
Causa
Potential for device breakage during use.
Acción
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
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
Dental Device, anti-snoring - Product Code LRK
Causa
Potential for device breakage during use.
Acción
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
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
Dental Device, anti-snoring - Product Code LRK
Causa
Potential for device breakage during use.
Acción
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
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
Dental Device, anti-snoring - Product Code LRK
Causa
Potential for device breakage during use.
Acción
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
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
Dental Device, anti-snoring - Product Code LRK
Causa
Potential for device breakage during use.
Acción
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.
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
System, radiation therapy, charged-particle, medical - Product Code LHN
Causa
Iba is initiating this recall to address an issue identified with adaptinsight software and to reduce risk related to this problem.
Acción
IBA mailed an Urgent Field Safety Notice to affected customers on 10/28/2016 to inform them of the issue. The issue will be solved in AdaPTinsights versions starting from Al 2.0. The solution was to be deployed on impacted IBA Proton Therapy sites by September 2017.
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
System, radiation therapy, charged-particle, medical - Product Code LHN
Causa
Iba is initiating this recall to notify its customers that the use of non-iba accessories and/or third party equipment or unauthorized modifications to an iba medical device may pose a safety risk.
Acción
IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.
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
System, radiation therapy, charged-particle, medical - Product Code LHN
Causa
Iba is initiating this recall to notify its customers that the use of non-iba accessories and/or third party equipment or unauthorized modifications to an iba medical device may pose a safety risk.
Acción
IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.
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.
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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Software anomaly, incorrect coding. some comments were not transfered when coming from the reference laboratory interface.
Acción
A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
Acción
Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.
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
Counter, Differential Cell - Product Code GKZ
Causa
Product elicits fluorescent signal interference due to contamination.
Acción
On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code ---
Causa
Brochures approved for international distribution only were distributed domestically.
Acción
The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.