IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
FDA device recall Z-2112-2014 · posted 2014-07-29 · Terminated
Recall details
- Recalling firm
- Wellspring Pharmaceutical Corporation
- Reason for recall
- Potential for microbial contamination of the product.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 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
- Date initiated
- 2014-03-25
- Date posted
- 2014-07-29
- Date terminated
- 2014-09-08
- Location
- Sarasota, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| L.A.M. IMP WOUND GEL (K123113) | Glycobiosciences, Inc. | 2012-12-11 |