Recall Z-0147-2027
- Recall number
- Z-0147-2027
- Event number
- 99948
- Firm
- INTEGRATED MEDCRAFT LLC
- Firm FEI
- 3030078769
- Product code
- OHO
- Status
- Open, Classified
- Initiated
- 2026-09-25
- Posted
- 2026-10-09
- Root cause
- Component change control
Product#
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.