Z-1663-2023 Class II Ongoing
FDA device recall Z-1663-2023 was initiated by TELEFLEX LLC on April 28, 2023 and is designated Class II. 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 applie… The recall status is ongoing. Affected quantity: 146,606 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146,606 units
Product Description
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
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.
Distribution Pattern
worldwide
Code Information
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