FDAFDA · Food and drugs·Recall number Z-0391-2023
Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
Published December 14, 2022 · Recall initiated: November 2, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 2200 Inc
- Distributor
- Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
- Lot
- UDI/DI 10885403040917, ALL LOTS
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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