Puracol collagen wound dressings recalled over elevated endotoxin levels
Medline is recalling Puracol and Puracol Plus collagen wound dressings after elevated endotoxin levels were identified in affected lots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: elevated endotoxin in a wound dressing may provoke an inflammatory or systemic response, and no injuries are stated.
Plain-English summary
Medline Industries, LP is recalling Puracol and Puracol Plus collagen wound dressings, covering MSC8522 (Puracol sterile 2" x 2") and MSC8622EP (Puracol Plus 2 x 2.2"). About 106,621 units were distributed nationwide in the United States, with a further 2,350 distributed to Mexico and Panama. The FDA has classified this recall as Class II.
Elevated endotoxin levels were identified in affected lots. Medline states the issue may elicit a 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.
Affected product covers Puracol lot P2090 (UDI-DI 10080196285860) and Puracol Plus lot PL2107 (UDI-DI 10080196296804).
Facilities can identify affected dressings by the product code, UDI and lot numbers above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Wound care
Distribution
Distributed nationwide across the United States.
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