Recall Z-1663-2023 ยท FZP Clip, Implantable
TELEFLEX LLC
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
| Date | May 30, 2023 (initiated Apr 28, 2023) |
| Status | Open, Classified |
| Reason | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures. |
| Root cause | Under Investigation by firm |
| Action | Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/28/2023 by FedEx 2nd day mail. The letter explained the issue, potential risk, and requested the following actions: Medical facilities: Cease use and distribution, and isolate the affected product. Circulate the notice to all affected departments. Distributors: Cease use and distribution, and isolate the affected product. Provide the notice to your customers. Teleflex is seeking return of the affected units. |
| Quantity | 146,606 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS Teleflex Medical, Nov 27, 2013 |