The Recall Desk
HighFDA (Devices)·Z-2112-2014·Announced 2014-08-06

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.

What this means for you

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: The recall involves a risk-of-harm product (wound dressing) with a potential for microbial contamination, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

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

Distributed in 13 states:

Related recalls

Same hazard · microbial contamination

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