Medical Device Safety and Recalls: Wellspring Pharmaceutical Corporation, IPM Wound Gel - Microbial Contamination

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Wellspring Pharmaceutical Corporation, IPM Wound Gel - Microbial Contamination

A recall has been issued for the Wellspring Pharmaceutical Corporation IPM Wound Gel.  One lot of IPM Wound Gel may be contaminated with bacteria (Pseudomonas Putida). Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.  There have not been any reports of injuries or death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm409283.htm

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