Z-0645-2021 Class II Terminated
FDA device recall Z-0645-2021 was initiated by GA HEALTH COMPANY LIMITED on November 3, 2020 and is designated Class II. Reason for recall: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure The recall status is terminated (terminated September 3, 2021). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 3, 2020
- Termination Date
- September 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Reason for Recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Distribution Pattern
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Code Information
Lot Numbers: 20031002 Unit UDI: 04897106952571 Box UDI: 14897106952578 Cartoon Box UDI: 24897106952575