FDA Device recall Z-2638-2014
Amerigel Wound Dressing Maximum Strength CAT# A2001
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of Amerigel Wound Dressing Maximum Strength CAT# A2001 by Amerx Health Care, citing not approved labeling claims (antimicrobial and autolytic debridement).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2638-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-11 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amerx Health Care |
| Distribution | US |
Product
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Reason
Not approved labeling claims (antimicrobial and autolytic debridement)
Identifiers
| code_info | Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05 |
|---|
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-2638-2014%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.