Integrated Medcraft Recalls FORWARD Gunshot Wound Kits Due to Sterile Pad Degradation
Integrated Medcraft is recalling FORWARD Gunshot Wound Kits because the sterile pad may degrade, potentially causing material to dislodge on or near wounds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II, and the hazard involves the potential dislodgement of nonwoven pad material on or near wounds. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Integrated Medcraft LLC is recalling 1,033 units of the FORWARD Gunshot Wound Kit, Model AFT-GSW. This is a subrecall of a kitted device from SafeGuard Medical. The recall was initiated after internal testing identified an issue affecting the device's sterile pad, which may cause the pad to degrade over time.
The degradation of the sterile pad may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound. The affected units were distributed nationwide in the states of Georgia and Virginia. The recall covers specific lot numbers, including IMC-00000024, IMC-00000034, and others listed in the agency record.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers should check their inventory for the affected model and lot numbers and follow instructions from the recalling firm or the FDA regarding the return or disposal of the product.
The recalled product
- Product
- FORWARD Gunshot Wound Kit; Model: AFT-GSW;
- Manufacturer
- INTEGRATED MEDCRAFT LLC
- Category
- Medical Device — Wound Care
- Affected units
- 1,033
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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