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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Item: 346VA; Lot Numbers: D3, E3, F3 Class II Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. 81 units Z-2264-2013
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic 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. Item: 345VA; Lot Number: F3 Class II Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. 9 units Z-2265-2013
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