| Class 1 Device Recall IPM Wound Gel | |
Date Initiated by Firm | March 25, 2014 |
Date Posted | July 29, 2014 |
Recall Status1 |
Terminated 3 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
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Product | IPM Wound Gel Rx Wound Dressing
IPM Wound Gel is indicated for the management of wound healing. |
Code Information |
Lot #3P3446 |
Recalling Firm/ Manufacturer |
Wellspring Pharmaceutical Corporation 5911 N Honore Ave Ste 211 Sarasota FL 34243-2612
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For Additional Information Contact | 941-312-4727 |
Manufacturer Reason for Recall | Potential for microbial contamination of the product. |
FDA Determined Cause 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = FRO
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