The Recall Desk
ModerateFDA (Devices)·Z-0403-2023·Announced 2022-12-14

CareFusion Bipolar Forceps Recalled: Incomplete Instructions for Power Supply

CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving incomplete Instructions For Use. The missing information on power supply interface and maintenance procedures is important for safe device operation. No illnesses or injuries have been reported.

Plain-English summary

CareFusion is recalling V. Mueller bipolar forceps due to incomplete instructions for use. The affected device is the TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS with a 1.5mm tip, overall length 10.5 inches (REF F-5022). The recall involves 32 units.

The Instructions For Use (IFU) provided by the manufacturer is missing critical information. Specifically, it lacks content regarding the interface with the device power supply and procedures for cleaning and maintenance. This information is necessary for safe and proper operation of the surgical instrument.

The affected devices were distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots of the product are included in the recall (UDI/DI 10885403041075).

The corrected V. Mueller bipolar forceps Instructions For Use contains the complete information regarding power supply interface and proper cleaning and maintenance procedures.

The recalled product

Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • improper-maintenance

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 10885403041075
  • ALL LOTS

Distribution

Distributed nationwide across the United States.