Wellspring Recalls IPM Wound Gel Rx Wound Dressing Due to Microbial Contamination
Wellspring Pharmaceutical is recalling IPM Wound Gel Rx Wound Dressing due to a potential for microbial contamination. The product is distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for microbial contamination of the product."
Plain-English summary
Wellspring Pharmaceutical Corporation is recalling 3,135 cartons of 4/10g tubes of IPM Wound Gel Rx Wound Dressing. The recall is being conducted because of a potential for microbial contamination of the product.
The affected product, identified by Lot #3P3446, is indicated for the management of wound healing. It was distributed worldwide, specifically in the United States (including Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia) and Canada.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
- Manufacturer
- Wellspring Pharmaceutical Corporation
- Category
- Medical Device — Wound Care
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #3P3446
Distribution
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