Presource Kit — Class II medical device recall Z-1690-2023
Ongoing recall by Cardinal Health 200, LLC, reported 2023-06-14, distributed in GA. Inadvertently released for distibution without sterility assurance.
| Recall number | Z-1690-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-06-06 |
| Reported by FDA | 2023-06-14 |
| Distributed | GA |
| Quantity | 5 units |
| Reason classes | sterility |
| Lot numbers | 019693 |
| Model numbers | SMA21LPUHJ |
Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reason for recall
Inadvertently released for distibution without sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1690-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.