Class II — INTEGRATED MEDCRAFT LLC
| Recalling firm | Integrated Medcraft LLC |
|---|---|
| Registered facility | INTEGRATED MEDCRAFT LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound. |
| Product | FORWARD Gunshot Wound Kit; Model: AFT-GSW; |
| Quantity | 1033 |
| Distribution | US Nationwide distribution in the states of GA, VA. |
| Initiated | 2026-09-25 |
| Classified | 2026-10-09 |
| Recall number | Z-0147-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — INTEGRATED MEDCRAFT LLC (Z-0147-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99948/
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