Recall Z-1663-2023
Teleflex LLC · initiated April 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1663-2023
- Initiated
- April 28, 2023
- Posted by FDA
- May 30, 2023
- Product code
- FZP – Clip, Implantable
- Quantity
- 146,606 units
- Distribution
- worldwide
- Recalling firm
- Teleflex LLC, Morrisville, NC