Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
This recall is currently active, issued June 6, 2023. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- April 6, 2023
- Posted
- June 6, 2023
- Recall Number
- Z-1690-2023
- Quantity
- 5 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Inadvertently released for distibution without sterility assurance.
Distribution
Distribution in the US to Georgia
Lot / Code Info
Catalog Number: SMA21LPUHJ; Lot Number: 019693
Root Cause
Process control
Action Taken
Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product.
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