FDA-Device2022-12-14Class II
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Carefusion 2200 Inc
Hazard
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Sold states
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
Affected count
100 units
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0382-2023Don't want to check this manually?
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