FDA DeviceClass IINotable
FDA Recall: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2"
Description
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Hazard
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Remedy
106,621 US; 2,350 OUS
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