Reported Sep 17, 2014 · Terminated

Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size,…

Integra York PA, 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: Integra York PA, Inc · 589 Davies Dr · York, PA · 17402-8630

Is this the product you have?

  • Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size
  • Red Catalogue Numbers730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid
Lot codes and dates
  • Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Blue; Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Gold; Container Lid, ¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size
  • Red Catalogue Numbers
    • 730422
    • 730521
    • 730522
    • 730523
    • 730524
    • 730621
    • 730622
Amount recalled
84

Where it was sold

Why it was recalled

Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.

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 Mar 10, 2015 · Data as of Sep 19, 5:31 PM UTC

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