Olympus Corporation of the Americas: Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheat

Hazard

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

Details from the source

Reason for recall: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. Distribution: US nationwide distribution. Quantity: 454 units Lot/code info: 1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots

UPC codes

04953170245466, 04953170245480, 04953170245503, 04953170245527

Source

Official record: FDA (Device enforcement) ↗

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