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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/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Karen LeFevere
973-709-7652
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.
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