O&M Halyard has recalled 848 cases of Procedure Masks with SO SOFT* Earloops (Yellow) and SOFT TOUCH II Surgical Masks (Blue). These masks fail to meet the bioburden (microbial cleanliness) testing requirements of the EN 14683 standard that is printed on their packaging. No incidents or injuries have been reported, but because the standard is listed on the box, the products must comply with it. Consumers should stop using these specific lots and contact their supplier or the manufacturer for instructions.
The masks failed to meet safety standards for microbial cleanliness printed on the packaging, which may pose a risk of infection or contamination in clinical environments. While the standard is not a requirement for sales in the United States, labeling the product as compliant when it is not creates a safety and quality concern.
211 cases affected.
637 cases affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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