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U.S. Department of Health and Human Services

Class 3 Device Recall Custom Tubing Kit

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  Class 3 Device Recall Custom Tubing Kit see related information
Date Initiated by Firm March 11, 2016
Create Date June 06, 2018
Recall Status1 Terminated 3 on June 07, 2019
Recall Number Z-2104-2018
Recall Event ID 80086
510(K)Number K080592  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Code Information Batch Number 3000020069, UDI Code 10607567203300;  Batch Number 3000021675, UDI Code 10607567203300
Recalling Firm/
Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact Karen LeFevere
Manufacturer Reason
for Recall
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
FDA Determined
Cause 2
Under Investigation by firm
Action Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to fieldactions@maquet.com.
Quantity in Commerce 19 total kits
Distribution The products were distributed to the following US states: AL, OR, and TX.
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