FDA-Device2019-01-16Class II

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.

Cardinal Health Inc.
Hazard

The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.

Sold states
US state of Florida
Affected count
182 packs
Manufactured in
7000 Cardinal Pl, Dublin, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2019

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