The Recall Desk
HighFDA (Devices)·Z-0409-2023·Announced 2022-12-14

Bipolar Forceps Recall Due to Incomplete Instructions for Use

BD is recalling CareFusion bipolar forceps due to incomplete Instructions for Use. The IFU is missing critical information about power supply interface and cleaning/maintenance procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: A surgical forceps is a risk-of-harm product. Missing critical Instructions for Use content about power supply interface and maintenance procedures creates potential for improper use or inadequate sterilization. Since no injuries have been reported and the hazard remains theoretical, this scores 3 (High) per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

BD is recalling the CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP (Model F-5125, overall length 225MM). Approximately 45 units have been distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

The Instructions for Use (IFU) provided with the device is incomplete. The missing content includes critical information regarding the device's interface with the power supply, as well as cleaning and maintenance procedures. Without complete instructions, users may be unable to properly operate, clean, and maintain the surgical instrument.

Healthcare facilities and professionals who received this device should obtain the corrected IFU from the manufacturer. The affected product is identified by UDI/DI 10885403041211, and all lot numbers are included in this recall. A corrected version of the IFU has been provided to address these documentation deficiencies.

The recalled product

Product
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • incomplete-instructions

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 10885403041211
  • ALL LOTS

Distribution

Distributed nationwide across the United States.

Related recalls

Same category