Carefusion recalls bipolar forceps with missing instructions for power supply and cleaning. Owners should check product details and contact Carefusion for guidance.
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.
Carefusion is recalling bipolar forceps that lack critical instructions for power supply and cleaning. This could lead to improper use if owners don't follow the missing safety steps.
The forceps lack instructions for connecting to power supplies and cleaning, which could cause improper use. Without these steps, there's a risk of damage or injury during medical procedures.
Medical professionals using these forceps for procedures are most at risk. Owners of the specific model with the UDI/DI 10885403040870 are affected.
Check for the model name 'Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335'. The UDI/DI number 10885403040870 identifies the affected units.
Identify the model and UDI/DI number to confirm if your forceps are affected.
The instructions for use are missing content related to power supply connections and cleaning, which could lead to improper use.
No, but you should check the product details to confirm if your forceps are affected and follow the instructions for safe use.
Carefusion has provided a reference to the V. Mueller Bipolar Forcep IFU for additional instructions.
We’ve drafted a message you can send Carefusion to request your refund or repair — edit it as you like.
Subject: Recall Z-0389-2023 — Carefusion Carefusion Hello, I own a Carefusion that is covered by recall Z-0389-2023 from Carefusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
