—#199907

Product

Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation

FDA product code: FZP — Clip, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K132658
Affected lot / code info: UDI/DI 24026704696394, Lot Numbers: 73A2200857, 73A2300018, 73A2300176, 73A2300326, 73A2300520, 73A2300778, 73D2200216, 73D2200559, 73E2200634, 73E2200874, 73E2201099, 73F2200193, 73F2200200, 73F2200482, 73F2200711, 73G2200168, 73G2200345, 73G2200560, 73G2200754, 73H2200115, 73H2200294, 73H2200433, 73H2200453, 73J2200747, 73J2200763, 73K2200014, 73K2200095, 73K2200101, 73K2200299, 73K2200566, 73K2200713, 73L2200064, 73L2200066

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: TELEFLEX LLC
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2023-04-28
Posted by FDA: 2023-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.