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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit

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  Class 2 Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit see related information
Date Initiated by Firm July 27, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on February 07, 2020
Recall Number Z-2179-2018
Recall Event ID 80081
510(K)Number K080592  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041

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 0607567203600
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 2		 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 27
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 and Original Applicant = MAQUET CARDIOPULMONARY AG
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