Presource Kit Total Joint Pack containing a double-wrapped basin… — Class II medical device recall Z-0702-2019
Terminated recall by Cardinal Health Inc., reported 2019-01-16, distributed in FL. The double wrapping of this custom kit basin set is not supported by the current sterility assurance validatio
| Recall number | Z-0702-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2018-11-16 |
| Classified | 2019-01-09 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2019-11-04 |
| Distributed | FL |
| Quantity | 182 packages |
| Reason classes | sterility |
| Lot numbers | 104405, 122793, 987948 |
Product
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Reason for recall
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
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-0702-2019. 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.