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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet HLM Tubing Pack

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 Class 2 Recall
Maquet HLM Tubing Pack
see related information
Date Posted September 12, 2010
Recall Status1 Terminated on August 10, 2011
Recall Number Z-2401-2010
Recall Event ID 56268
Premarket Notification
510(K) Number
K053025 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product Maquet HLM Tubing Pack; Bioline Coating
Code Information Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
For Additional Information Contact Whiting Torning
973-709-9774
Manufacturer Reason
for Recall
The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
Quantity in Commerce 5 units
Distribution Distribution: Pennsylvania
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWE and Original Applicant = MAQUET CARDIOPULMONARY AG
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