R A Medical Services has recalled 10 units of the MINISCAV (tm) Vacuum Pump because of inadequate documentation of acceptance activities. This means there is insufficient proof that the devices were properly tested and verified to meet safety and performance standards before being distributed. These vacuum pumps were distributed specifically to Ohio and are identified by serial numbers N/AB/10514 through N/AB/10523.
Inadequate documentation of acceptance activity means the manufacturer cannot guarantee the device functions correctly or safely, which could potentially lead to device failure or unexpected performance during medical procedures. While no injuries have been reported, the lack of quality control documentation creates a moderate risk that a defective unit could reach a patient or healthcare provider.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES ยท Raw API Response
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