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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Recall Number Z-1847-2012
Classification Class II
Code Info LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Product Distributed Qty 28248 units
Reason For Recall Potential for the sterility barrier to be compromised.

Event Detail

Event Id 61942
Product Type Devices
Status Ongoing
Recalling Firm Covidien LP
City North Haven
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA√ĎA France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
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