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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Recall Number Z-1063-2013
Classification Class II
Code Info Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
Product Distributed Qty 6,751 units
Reason For Recall Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

Event Detail

Event Id 64420
Product Type Devices
Status Ongoing
Recalling Firm Covidien LP
City North Haven
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.