Recall Z-1521-2013 ยท NWV Laparoscopic Accessories, Gynecologic
Applied Medical Resources Corp
Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
| Date | Jun 7, 2013 (initiated May 1, 2013) |
| Status | Terminated |
| Reason | Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely; |
| Root cause | Nonconforming Material/Component |
| Action | Applied Medical notified customers of the recall beginning on May 13, 2013. The "URGENT: MEDICAL DEVICE RECALL" letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact the firm at (949) 713-8041. |
| Quantity | 127,305 units |
| Distribution | Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.