Medline Industries, LP: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution nationwide US. International distribution to Mexico and Panama. Quantity: 106,621 US; 2,350 OUS Lot/code info: MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107

UPC codes

10080196285860, 40080196285861, 10080196296804, 40080196296805

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.