FDA Device recall Z-0500-2015
Amerigel Saturated Gauze Dressing Wound management
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Amerigel Saturated Gauze Dressing Wound management by Amerx Health Care, citing formulation deviation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0500-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | US |
Product
Amerigel Saturated Gauze Dressing Wound management
Reason
Formulation deviation
Identifiers
| code_info | Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0500-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.