FDA Device recall Z-0702-2019
Presource Kit Total Joint Pack containing a double-wrapped basin component
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Presource Kit Total Joint Pack containing a double-wrapped basin component by Cardinal Health, citing the double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0702-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-16 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health |
| Distribution | FL |
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
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Identifiers
| code_info | Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0702-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.