Olympus Corporation of the Americas: 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

Hazard

There have been complaints that the clip did not come out of the tube sheath during the procedure.

Details from the source

Reason for recall: There have been complaints that the clip did not come out of the tube sheath during the procedure. Distribution: US Nationwide Distribution Quantity: 65.9 boxes (373 pieces) Lot/code info: 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

UPC codes

14953170353106, 14953170353113, 14953170353120, 14953170353168

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.