The recall was issued after tests discovered that one lot of IPM Wound Gel was contaminated with Pseudomonas Putida, a common bacteria that lives in soil and freshwater environments all over the world.
Unfortunately, using a contaminated wound gel can cause serious adverse health consequences, including bacterial infections, sepsis (blood poisoning), limb loss, and death. No injuries or deaths have been reported.
The recall affects Lot # 3P3446 by Wellspring Pharmaceutical Corporation and distributed by Edwards Pharmaceuticals Inc. The product was manufactured on November 14, 2013 and distributed between December 5, 2013 – February 4, 2014 and also March 12-20, 2014.
The firm notified customers about the recall on March 25, 2014 with an “Urgent Medical Device Recall” letter informing them of the problem. Customers were instructed to return the affected products for destruction, complete a response form, and notify any customers who received the product.
The FDA determined this is a Class I recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
What is IPM Wound Gel?
IPM Wound Gel is primarily used in hospitals for wound care, including leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), dead, damaged or infected tissue (debrided wounds), and second degree wounds.
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