Class II — Revmedx Inc
| Recalling firm | RevMedx, Inc. |
|---|---|
| Registered facility | REVMEDX, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile. |
| Product | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation. |
| Quantity | 5004 units |
| Distribution | US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia. |
| Initiated | 2015-08-12 |
| Classified | 2015-09-11 |
| Terminated | 2015-09-17 |
| Recall number | Z-2762-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Revmedx Inc (Z-2762-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72019/
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