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Covidien Llc recalls Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the
Recalled August 18, 2021 · FDA recall Z-2240-2021 · Covidien
Hazard
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located · FDA Class II
Units
96 units
Sold at
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
Description
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
Product
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Manufacturer(s)
Covidien Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →