Z-1418-2023 Class II Ongoing
FDA device recall Z-1418-2023 was initiated by Olympus Corporation of the Americas on February 23, 2023 and is designated Class II. Reason for recall: There have been complaints that the clip did not come out of the tube sheath during the procedure. The recall status is ongoing. Affected quantity: 65.9 boxes (373 pieces).
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- February 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65.9 boxes (373 pieces)
Product Description
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Reason for Recall
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Distribution Pattern
US Nationwide Distribution
Code Information
1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V