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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 Device Recall MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector see related information
Date Initiated by Firm September 07, 2010
Date Posted October 06, 2010
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-0011-2011
Recall Event ID 56728
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 NJ 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		 Device Design
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 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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