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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description Maquet 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
Recall Number Z-2210-2012
Classification Class II
Code Info 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
Product Distributed Qty 20 devices US; 122 devices foreign
Reason For Recall Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

Event Detail

Event Id 62471
Product Type Devices
Status Ongoing
Recalling Firm Maquet Inc.
City Wayne
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including MI, MN and Internationally