FDA Medical Device Recalls (openFDA)
Amerx Health Care Corp.: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
- Recall number
- Z-2249-2016
- Recalling firm
- Amerx Health Care Corp.
- Product
- Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
- Status
- Terminated
- Initiated
- 2016-05-20
- Posted
- not on file
- Terminated
- 2016-12-14
- Reason
- Product did not meet specifications for Zinc Acetate (OOS).
- Root cause
- Other
- Action
- Initial recall notification was sent to distributors, informing them of the voluntary recall and providing instructions on expanding the recall to the wholesale level. Distributors were instructed to identify recalled product in their inventory, quarantine any recalled product, and to complete and fax back a Recall Response Form. Contact information was provided for those with questions: 1-800-448-9599 and recall@amerxhc.com.
- Quantity
- 6,993 Units
- Distribution
- AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.
- Lot, serial or model codes
- Lot # 668
- 510(k) numbers
- ["K970133"]
- PMA numbers
- not on file
- Product code
- KMJ
- Firm FEI
- 1000525408
- Firm city
- Clearwater
- 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