Recall Z-1730-2018

Reason for recall

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.

FDA-determined cause: Process control

Action taken

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.