Recall archive / FDA device enforcement
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery — FDA record Z-1690-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
- Reason
- Inadvertently released for distibution without sterility assurance.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 5 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1690-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: SMA21LPUHJ; Lot Number: 019693 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in the US to Georgia
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- Apr 6, 2023
- Center classification date
- Jun 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.