Z-2264-2013 Class II Terminated

Recalled by Endoplus, Inc. — Mundelein, IL

Recall Details

Product Type
Devices
Report Date
October 2, 2013
Initiation Date
July 15, 2013
Termination Date
February 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
81 units

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.

Reason for Recall

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Distribution Pattern

Distributed in the states of FL, TX, and VA.

Code Information

Item: 346VA; Lot Numbers: D3, E3, F3