Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that requi
FDA device recall Z-1663-2023 · posted 2023-05-30 · Open, Classified
Recall details
- Recalling firm
- TELEFLEX LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FZP
- Quantity affected
- 146,606 units
- Distribution
- worldwide
- Date initiated
- 2023-04-28
- Date posted
- 2023-05-30
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS (K132658) | Teleflex Medical | 2013-11-27 |