August 13, 2014 — IPM Wound Gel has been recalled after one lot tested positive for bacterial contamination. Use of this product on a wound could result in a bacterial infection or other adverse health consequences.
No injuries or deaths have been reported.
The bacteria, Pseudomonas Putida, is commonly found in freshwater and soil environments all over the world. If it is introduced in a wound, there is a possibility that it could cause a bacterial infection. The most severe infections occur when bacteria contaminates the blood, causing sepsis (blood poisoning), limb loss, and even death.
The recall affects Lot # 3P3446, manufactured on November 14, 2013, distributed between December 5, 2013 – February 4, 2014 and also March 12-20, 2014.
IPM Wound Gel is used in hospitals to maintain tissue hydration and support the healing process for leg ulcers, pressure ulcers, diabetc ulcers, surgical wounds, second degree wounds, and tissue that is dead, damaged or infected (debrided wounds).
The manufacturer, Wellspring Pharmaceutical Corporation, and the distributor, Edwards Pharmaceuticals, Inc., notified customers about the recall with an “Urgent Medical Device Recall” letter on March 25, 2014. Customers were instructed to return the recalled products so they could be destroyed, complete a response form, and notify anyone who received the product through redistribution.
The Class I recall was issued after the U.S. Food and Drug Administration (FDA) determined there is a reasonable probability that use of this product could result in severe injury or death. Class I recalls are the most serious type of recall.
Do I have an IPM Wound Gel Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting IPM Wound Gel induced injury cases in all 50 states. If you or somebody you know has been injured by a bacterial infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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