Cardinal Health Inc. recalls Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients…
- Recall date
- November 16, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0702-2019
- FDA classification
- Class II
- Brand / firm
- Cardinal Health Inc.
- Sold / distributed
- US state of Florida
Why it was recalled
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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