Carefusion 2200 Inc recalls Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM),…

Recall date

November 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0387-2023

FDA classification

Class II

Brand / firm

Carefusion 2200 Inc

Sold / distributed

Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304