FDA DeviceClass IINotable
FDA Recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Description
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Hazard
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Remedy
190 units
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