FDAFDA · Food and drugs·Recall number Z-2265-2013
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.
Published October 2, 2013 · Recall initiated: July 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endoplus, Inc.
- Distributor
- Distributed in the states of FL, TX, and VA.
- Lot
- Item: 345VA; Lot Number: F3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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