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Class 1 Device Recall IPM Wound Gel |
![see related information](../images/related-info.gif) |
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
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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.
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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
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Manufacturer Reason for Recall |
Potential for microbial contamination of the product.
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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 and Original Applicant = GLYCOBIOSCIENCES, INC
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