Integrated Medcraft Llc: First Aid Kit Without Drug
Recall Summary Integrated Medcraft LLC is recalling the FORWARD Gunshot Wound Kit (Model AFT-GSW) due to a defective sterile pad that may break down over time and shed material into or near a wound. The kit was distributed nationwide, with primary distribution in Georgia and Virginia. This is a Class I recall, the most serious classification.
- Recalling firm
- INTEGRATED MEDCRAFT LLC
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of GA, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f619f92e-e58b-468c-8f47-d089efc66d25