FDA recall Z-0416-2023

Carefusion 2200 Inc · Class II · device

Product

CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-11-02
Report date: 2022-12-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2023