FDA-Device2022-12-14Class II

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124

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
21 units
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2023

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