Reported Jan 16, 2019 · Terminated
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients…
Cardinal Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health Inc. · 7000 Cardinal Pl · Dublin, OH · 43017-1091
Is this the product you have?
- Presource Kit Total Joint Pack containing a double-wrapped basin component
- Product UsageThis kit is used on patients undergoing joint replacement knee or hip
- Lot codes and dates
- Product code
SOP22TJCLK Lot numbers # 104405122793and 987948
- Product code
- Amount recalled
- 182 packs
Where it was sold
Why it was recalled
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
This product could cause temporary or reversible health problems — stop using it.
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