Recall Z-0702-2019 ยท LRO General Surgery Tray
Cardinal Health Inc.
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.
| Date | Nov 16, 2018 |
| Status | Terminated |
| Reason | The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation. |
| Root cause | Unknown/Undetermined by firm |
| Action | As only one customer is potentially impacted, in the interest of prompt action and notification, a teleconference was held on Friday, November 16, 2018 with the customer to communicate the impending actions. During this teleconference, the customer was informed that an HHE and field corrective action was in-process and that a study was being initiated to determine that their requested packaging configuration was acceptable. The customer also was informed that they should not continue to use the impacted double wrapped basin, and the components contained within, until the study was completed. |
| Quantity | 182 packs |
| Distribution | US state of Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.