Approximately 489,803 units of SURGICEL FIBRILLAR (an absorbable surgical dressing used to control bleeding) are being recalled because some foil pouches were found torn open. This defect, caused by a packaging machine, compromises the sterile barrier of the product. The recall affects two product sizes (Product Numbers 1961 and 1963) distributed worldwide, including across the United States. Patients may be at risk of infection if the non-sterile product is used during surgery.
The torn foil pouches mean the product is no longer sterile; using a compromised surgical dressing during an operation can introduce bacteria into the surgical site, potentially leading to serious infections.
Contact the manufacturer or healthcare provider
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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