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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Recall Number Z-2264-2013
Classification Class II
Code Info Item: 346VA; Lot Numbers: D3, E3, F3
Product Distributed Qty 81 units
Reason For Recall Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Event Detail

Event Id 66063
Product Type Devices
Status Ongoing
Recalling Firm Endoplus, Inc.
City Mundelein
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of FL, TX, and VA.