Integrated Medcraft FORWARD Gunshot Wound Kit recalled for sterile pad degradation risk
What this means
Internal testing found that the sterile pad in the FORWARD Gunshot Wound Kit (Model AFT-GSW) may degrade over time. This degradation could cause small pieces of the pad material to come loose and contaminate the wound during treatment.
- Check your kit lot number against the FDA notice at fda.gov
- Do not use affected kits; contact Integrated Medcraft for instructions on replacement or disposal
- If you have already used an affected kit, consult your healthcare provider
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2027Want us to check the next one for you?
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