The Recall Desk
ModerateFDA (Devices)·Z-0406-2023·Announced 2022-12-14

Bipolar Forceps Recall: Missing Instructions for Power Supply and Maintenance

CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.

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 a Class II recall for incomplete instructions on a surgical device. No illnesses or injuries have been reported. The hazard is primarily a documentation issue involving missing instructions for critical device functions—power supply interface and maintenance procedures.

Plain-English summary

CareFusion 2200 Inc is recalling the V. Mueller Round Handle Bayonet Bipolar Forceps (Model F-5069, 1.0MM tip, 10-1/2" overall length) due to incomplete Instructions for Use documentation. The manufacturer has determined that the Instructions for Use provided by CareFusion lacks certain content that is contained in the manufacturer's original instructions, specifically regarding the interface with the device power supply and cleaning and maintenance procedures.

The recalled bipolar forceps were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. The recall affects 19 units identified by UDI/DI 10885403041174 and impacts all lot numbers.

The missing instructional content could result in improper handling, cleaning, or maintenance of the device, or incorrect use with the power supply system. Healthcare facilities and medical professionals using this device should immediately obtain and reference the complete manufacturer Instructions for Use.

No injuries or illnesses have been reported in connection with this device. Users should contact CareFusion 2200 Inc or their device supplier for the correct and complete Instructions for Use.

The recalled product

Product
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • missing-maintenance-info
  • missing-power-supply-info

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 10885403041174
  • ALL LOTS

Distribution

Distributed nationwide across the United States.