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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Recall Number Z-1635-2014
Classification Class II
Code Info Lot Numbers: 00116169 and 00115866
Product Distributed Qty 540 units
Reason For Recall Grasper jaw may break when force is applied to the jaw

Event Detail

Event Id 68012
Product Type Devices
Status Ongoing
Recalling Firm Microline Surgical
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.