Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
FDA device recall Z-1690-2023 · posted 2023-06-06 · Open, Classified
Recall details
- Recalling firm
- Cardinal Health 200, LLC
- Reason for recall
- Inadvertently released for distibution without sterility assurance.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OHD
- Quantity affected
- 5 units
- Distribution
- Distribution in the US to Georgia
- Date initiated
- 2023-04-06
- Date posted
- 2023-06-06
- Location
- Waukegan, IL
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