Device recall
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
- Recall number
- Z-0147-2027
- Event id
- 99948
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- INTEGRATED MEDCRAFT LLC
- Report date
- Oct 21, 2026
- Posted
- Oct 9, 2026
- Initiated
- Sep 25, 2026
- Center classification date
- Oct 9, 2026
- Product code
- OHO
- Device type
- First Aid Kit Without Drug
- 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.
- Root cause
- Component change control
- Quantity
- 1033
- Code info
- Model: ATF-GSW; UDI-DI: 00850056748063; Lot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-00000076, IMC-00000081, IMC-00000082, IMC-00000083, IMC-00000084, IMC-00000085, IMC-00000094, IMC-00000148, IMC-00000149, IMC-00000152, IMC-00000153, IMC-00000154, IMC-00000173, IMC-00000174, IMC-00000179, IMC-00000186, IMC-00000187;
- Distribution
- US Nationwide distribution in the states of GA, VA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- East Hampton, CT, United States