Class 1 Device Recall IPM Wound Gel

• Date Initiated by Firm: March 25, 2014
• Date Posted: July 29, 2014
• Recall Status: Terminated on September 08, 2014
• Recall Number: Z-2112-2014
• Recall Event ID: 68556
• 510(K)Number: K123113
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
• Code Information: Lot #3P3446
• FEI Number: 3008139297
• Recalling Firm/ Manufacturer: Wellspring Pharmaceutical Corporation; 5911 N Honore Ave Ste 211; Sarasota FL 34243-2612
• For Additional Information Contact: 941-312-4727
• Manufacturer Reason for Recall: Potential for microbial contamination of the product.
• FDA Determined Cause: Nonconforming Material/Component
• Action: WellSpring Pharmaceutical Corporation notified customers on March 25, 2014 via e-mail. The notification identified the affected product, the problem, and directed consignees to return all products.
• Quantity in Commerce: 3,135 cartons of 4/10g tubes
• Distribution: Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRO