Recall Z-1621-2016 ยท FZP Clip, Implantable
Applied Medical Resources Corp
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
| Date | May 6, 2016 (initiated Apr 1, 2016) |
| Status | Terminated |
| Reason | Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels. |
| Root cause | Nonconforming Material/Component |
| Action | Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60698158@appliedmedical.com or faxing |
| Quantity | 559,274 |
| Distribution | U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011236 | MODIFICATION TO IMPLANTABLE CLIP Applied Medical Resources Corp., May 14, 2001 |