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 # 104405
    • 122793
    • and 987948
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2019 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.