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U.S. Department of Health and Human Services

Class 2 Device Recall MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector

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 Class 2 Recall
MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector
see related information
Date Posted October 06, 2010
Recall Status1 Terminated on September 25, 2012
Recall Number Z-0011-2011
Recall Event ID 56728
Premarket Notification
510(K) Number
K080592 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
Code Information Lot number 70052718 and 70048867
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan Mandy
973-995-8968
Manufacturer Reason
for Recall
Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form. Maquet Customer Service can bre contacted at 800-777-4222.
Quantity in Commerce 22 items
Distribution Worldwide Distribution: USA State of IL and country of the Netherlands.
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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