Class 2 Device Recall Custom Tubing Pack with Bioline Coating

• Date Initiated by Firm: October 19, 2017
• Create Date: May 08, 2018
• Recall Status: Terminated on April 24, 2020
• Recall Number: Z-1724-2018
• Recall Event ID: 79873
• 510(K)Number: K080592
• Product Classification: Reservoir, blood, cardiopulmonary bypass - Product Code DTN
• Product: BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
• Code Information: Lot 3000065224
• Recalling Firm/ Manufacturer: Datascope Corporation; 15 Law Dr; Fairfield NJ 07004-3206
• For Additional Information Contact: Ms. Karen LeFevere; 973-709-7652
• Manufacturer 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: 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.
• Quantity in Commerce: 18
• Distribution: Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTN and Original Applicant = MAQUET CARDIOPULMONARY AG