FDA Medical Device Recalls (openFDA)
Wellspring Pharmaceutical Corporation: IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
- Recall number
- Z-2112-2014
- Recalling firm
- Wellspring Pharmaceutical Corporation
- Product
- IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
- Status
- Terminated
- Initiated
- 2014-03-25
- Posted
- 2014-07-29
- Terminated
- 2014-09-08
- Reason
- Potential for microbial contamination of the product.
- Root 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
- 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.
- Lot, serial or model codes
- Lot #3P3446
- 510(k) numbers
- ["K123113"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3008139297
- Firm city
- Sarasota
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28