FDA recall Z-1690-2023
Cardinal Health 200, LLC · Class II · device
Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reason for recall
Inadvertently released for distibution without sterility assurance.
Distribution
Distribution in the US to Georgia
Key facts
- Status
- Ongoing
- Initiation date
- 2023-04-06
- Report date
- 2023-06-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2023