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U.S. Department of Health and Human Services

Class 3 Device Recall MAQUET Bioline Connectors

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 Class 3 Recall
MAQUET Bioline Connectors
see related information
Date Posted March 16, 2011
Recall Status1 Terminated on September 13, 2012
Recall Number Z-1666-2011
Recall Event ID 58053
Premarket Notification
510(K) Number
K080592 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
Code Information BEQ-HG 0284 Connector 3/8" x 3/8" Lot 70041098; BEQ-HG 1113 Connector 3/16" x 3/16" Lot 70041096 (note that this code was in the connector mispackaged in the box)
Recalling Firm/
Manufacturer
Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne, New Jersey 07470-2094
For Additional Information Contact Ms. Susan Mandy
201-995-8782
Manufacturer Reason
for Recall
Tubing connectors incorrectly packaged and labeled.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
Quantity in Commerce 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors
Distribution Nationwide distribution: USA state of CA.
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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