Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
FDA Recall Z-1663-2023 · Posted 2023-05-30
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Recalling FirmTELEFLEX LLC
Recall StatusOpen, Classified
Product CodeFZP
Date Initiated2023-04-28
Product Quantity146,606 units
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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