Class 2 Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit

• Date Initiated by Firm: July 27, 2017
• Create Date: October 11, 2018
• Recall Status: Terminated on February 07, 2020
• Recall Number: Z-2178-2018
• Recall Event ID: 80081
• 510(K)Number: K080592
• Product Classification: Tubing, pump, cardiopulmonary bypass - Product Code DWE
• Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
• Code Information: UDI 0607567204133
• Recalling Firm/ Manufacturer: Datascope Corporation; 15 Law Dr; Fairfield NJ 07004-3206
• For Additional Information Contact: Barb Smith; 973-244-6100
• Manufacturer Reason for Recall: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 7/27/17, an Urgent Safety Alert was issued to customers of the Cardiovascular Procedure Kit with LN130B Over-pressure Safety Valves. The safety alert instructed customers to perform the following: Please examine your inventory immediately to determine if you have unused kits of the batch numbers listed. If so, please follow the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. It is possible that custom tubing kits with the affected valves may have already been used without issue. Customers were instructed to test the valve prior to use. The notice was sent to customers again on 10/3/17 and 12/12/17. On 1/11/18, Urgent Medical Device Recall letters were sent to customers. The letters included the following instructions: Terumo CVS now recommends removal of any remaining product from your inventory. A review of our records indicates that you have received the following Maquet/Getinge Custom Tubing Kit batch numbers affected by the Terumo Cardiovascular Systems Medical Device Recall (refer to information provided in the table below). Please examine your inventory immediately to determine if you have unused custom tubing kits of the batch numbers listed. If so, please remove the affected products, quarantine them and follow the instructions for returning the product to Maquet/Getinge for full credit. It is possible that custom tubing kits with the affected valves may have already been used without issue. The Terumo Cardiovascular Systems Medical Device Recall affects the Custom Tubing Kit with LN130B Over-pressure Safety Valve distributed by Maquet/Getinge having lot/batch numbers listed above; no other product lot/batch numbers that were delivered to you are affected. Instructions for returning affected product: 1. Review this notice and Terumos Medical Device Recall Notice (attached). 2. Ensure that all users (i.e. perfusionist, operating room staff and biomedical staff) receive notice
• Quantity in Commerce: 10
• Distribution: The products were distributed to the following US states: IA and FL.
• 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 = DWE