Class IIDeviceOngoing

INTEGRATED MEDCRAFT LLC

FORWARD Gunshot Wound Kit; Model: AFT-GSW;

Reason for recall

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.

Details

Recall number: Z-0147-2027
Event ID: 99948
Recall initiated: Sep 25, 2026
Classified: Oct 9, 2026
Reported: Oct 21, 2026
Quantity: 1033
Distribution: US Nationwide distribution in the states of GA, VA.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: East Hampton, CT, United States
Lot / 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;