Recall Z-0702-2019— Cardinal Health Inc.
Class II · Terminated
Class II FDA medical device recall by Cardinal Health Inc., initiated 2018-11-16, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-16
- Terminated
- 2019-11-04
- Firm location
- Dublin, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.