FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Official notice from a government agency or its published feed.
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.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of GA, VA.
Hazard: 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 degra…
View the FDA enforcement report ↗ ← All reports