Z-1853-2022 Class II Ongoing
FDA device recall Z-1853-2022 was initiated by Surgical Innovations Ltd on January 20, 2022 and is designated Class II. Reason for recall: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- January 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Reason for Recall
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Distribution Pattern
US: MA
Code Information
Part/UDI-DI/Lot: YC0507001/05051986001890/735652