Recall Z-0147-2027 ยท OHO First Aid Kit Without Drug
INTEGRATED MEDCRAFT LLC
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
| Date | Oct 9, 2026 (initiated Sep 25, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On September 25, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Immediately discontinue use of any product matching the affected item(s) and lot number(s) listed in the item table above. Inspect inventory for affected product. If you have no products matching the affected item(s), please fill out the acknowledge receipt form (referenced below) and indicate that you have none of these products in inventory. 2. A copy of the Urgent Medical Device Recall from Safeguard Medical has been included for reference. 3. If you have product affected by this not |
| Quantity | 1033 |
| Distribution | US Nationwide distribution in the states of GA, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.