Issued by the US Food and Drug Administration, naming Kimberly-Clark Worldwide, Inc..
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Quoted from the record as published. If a product is not described here, this notice does not tell us whether it was affected.
The FDA’s least serious class: use of the product is not likely to cause adverse health consequences. Often a labelling or packaging fault.
This is the agency’s own definition of the class. We do not assign classes and we do not rank them against each other.
Regulates most packaged food, drugs and devices. Its recall records are published weekly in the Enforcement Report.
We have not matched this notice to any product in our database — usually because it named no barcode we hold. Products may still have been affected.
This notice concerns the product line itself or how it was produced.
The FDA publishes this notice through its enforcement API, so the link below returns raw JSON rather than a readable page. It is the primary record and we cite it as such; everything above is our transcription of it.
To see it in the FDA’s own words, search the reference number Z-2425-2012 in the Search the FDA Enforcement Report. The FDA publishes no direct link to an individual recall.