United StatesPuracol (MSC8522, collagen dressing, sterile 2" x 2", Lot P2090, UDI-DI 10080196285860 each / 40080196285861 case) and Puracol Plus (MSC8622EP, collagen dressing 2" x 2.2", Lot PL2107, UDI-DI 10080196296804 each / 40080196296805 case) wound dressings are affected. They were recalled for elevated endotoxin levels, which may cause strong inflammatory responses including local tissue irritation, delayed wound healing, systemic effects such as fever and hypotension, and in severe cases septic shock.
What's being recalled
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic distribution nationwide US. International distribution to Mexico and Panama.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)