Recall Z-0147-2027— INTEGRATED MEDCRAFT LLC
Class II · Ongoing
Class II FDA medical device recall by INTEGRATED MEDCRAFT LLC, initiated 2026-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: FORWARD Gunshot Wound Kit; Model: AFT-GSW;. 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..
- Recalling firm
- INTEGRATED MEDCRAFT LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-25
- Firm location
- East Hampton, CT, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.