Z-1690-2023 Class II Ongoing
FDA device recall Z-1690-2023 was initiated by Cardinal Health 200, LLC on April 6, 2023 and is designated Class II. Reason for recall: Inadvertently released for distibution without sterility assurance. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reason for Recall
Inadvertently released for distibution without sterility assurance.
Distribution Pattern
Distribution in the US to Georgia
Code Information
Catalog Number: SMA21LPUHJ; Lot Number: 019693