Carefusion recalls specific neuro/spine bipolar forceps due to missing instructions for power supply and cleaning. Affected models include F-5304 with UDI 10885403041297. No immediate action needed but ensure you have complete instructions.
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 certain neuro/spine bipolar forceps because their instructions for use are incomplete. This means users might not know how to safely clean or connect the device to power, which could lead to improper use or damage.
The missing instructions could lead to improper cleaning or power supply connections. This might cause device damage or improper use during medical procedures, but does not pose an immediate risk of injury.
Medical professionals using Carefusion's neuro/spine bipolar forceps for surgery or procedures are most at risk. Patients are not affected directly but could be impacted if improper use occurs.
Check for the model name 'CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOL 0.5MM TIP, ANGLED-UP, FINE' with overall length 8-3/4" (225MM). The unique identifier (UDI) 10885403041297 applies to all lots.
Ensure you have the complete Instructions for Use (IFU) for the device, as missing content could affect safe use.
Carefusion determined that the Instructions for Use provided by BD are missing content related to power supply and cleaning, which could lead to improper use.
No immediate action is required, but you should ensure you have the complete instructions for safe use.
Check if you have the model with UDI 10885403041297 and ensure you have the full instructions for use.
We’ve drafted a message you can send Carefusion to request your refund or repair — edit it as you like.
Subject: Recall Z-0416-2023 — Carefusion Carefusion Hello, I own a Carefusion that is covered by recall Z-0416-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
