Medical Devices

Wellspring Pharmaceutical Corporation, IPM Wound Gel - Microbial Contamination

Recall Class: Class I

Date Recall Initiated: March 25. 2014

Product: IPM Wound Gel, Lot # 3P3446, cartons of 4, 10g tubes

Manufacturing Date: November 14, 2013
Distribution Dates: December 5, 2013 – February 4, 2014 and March 20-12, 2014

Use: IPM Wound Gel is used primarily in hospitals for wound care. It is used to care for: 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.

The Over-the-Counter IPM Wound Gel is not included in this recall.

Recalling Firm:
Wellspring Pharmaceutical Corporation
5911 N Honore Avenue, Suite 211
Sarasota, Florida 34243-2612

Distributor:
Edwards Pharmaceuticals Inc.
111 Mulberry Street,
Ripley, Mississippi 38663

Reason for Recall: 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.

Public Contact: Customers with questions about this recall may contact the firm at 1-866-337-4500, Monday through Friday, 8:30 a.m. - 4:30 p.m., Eastern Time.

FDA District: Florida District Office

More Information about this Recall:
On March 25, 2014, the firm sent its customers an Urgent Medical Device Recall letter by email informing them of the product, problem, and action to be taken. The firm requested customers to:

  • Return the affect products for destruction.
  • Complete the pre-paid response form that was included in the email.
  • Notify any customers who received the product through redistribution.

About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 08/13/2014
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