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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet

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  Class 2 Device Recall Maquet see related information
Date Initiated by Firm May 14, 2013
Date Posted June 21, 2013
Recall Status1 Terminated 3 on September 18, 2014
Recall Number Z-1572-2013
Recall Event ID 65417
Product Classification Cannula injections - Product Code FGY
Product MAQUET GETINGE GROUP Arterial Cannula OD

Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
Code Information Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566
Recalling Firm/
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Karen LeFevere
Manufacturer Reason
for Recall
The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
FDA Determined
Cause 2
Packaging process control
Action Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
Quantity in Commerce 100 units (60 Domestic; 40 International)
Distribution Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
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.