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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Getinge Group Pediatric Arterial Cannula

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 Class 2 Device Recall Maquet Getinge Group Pediatric Arterial Cannulasee related information
Date Initiated by FirmMay 29, 2012
Date PostedAugust 15, 2012
Recall Status1 Terminated 3 on April 03, 2014
Recall NumberZ-2210-2012
Recall Event ID 62471
510(K)NumberK023251 
Product Classification Cannula, arterial, cardiopulmonary bypass (cpb), embolism protection - Product Code NCP
ProductMaquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
Code Information 510k023251  US Catalog Number 161412 Batch Number 92048923   Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578 
FEI Number 3008355164
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information ContactMs. Karen LeFevere
973-709-7652
Manufacturer Reason
for Recall		Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
FDA Determined
Cause 2		Device Design
ActionMaquet issued Urgent Device 2, Recall letters/Urgent Product Recall Forms dated May 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their current stock and identify any affected product and remove from their inventory. Customers were instructed to contact the customer service department at 800-777-4222 (option #2, followed by option #2). Customers were also instructed to completed the enclsoed Recall Form to acknowledge receipt of the notification and to document the current status of the devices shipped to their facility. For questions regarding this recall call 973-709-7660.
Quantity in Commerce20 devices US; 122 devices foreign
DistributionWorldwide Distribution - USA including MI, MN and Internationally
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) Database510(K)s with Product Code = NCP
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