Gunshot Wound Kit Recall: FORWARD AFT-GSW
An FDA recall has been issued for 1,033 Forward Gunshot Wound Kit (Model AFT-GSW) distributed nationwide in the United States, including Georgia and Virginia. The recall involves a subrecall of a kitted device from SafeGuard Medical due to internal testing identifying an issue with the sterile pad that may degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to it.
| Brand | 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. |
| Severity | moderate |
| Units affected | 1033 |
| Distribution | US Nationwide distribution in the states of GA, VA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the affected kit immediately and set it aside.
- Check your kit’s lot numbers against the recall list and contact SafeGuard Medical or Integrated Medcraft LLC for guidance on return or replacement.
- Do not rely on this kit for wound care until you receive a replacement.
- If you have used the kit and notice pad fragments or any symptoms, seek medical advice.
How to identify the recalled item
| Lot / date codes | 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; |
|---|---|
| Lot / date codes | 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; |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other INTEGRATED MEDCRAFT LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.