The Recall Desk
ModerateFDA (Devices)·Z-0399-2023·Announced 2022-12-14

CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

CareFusion is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.

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 Class II recall is primarily a documentation deficiency with no reported injuries or illnesses. The missing IFU content covers power supply interface and cleaning/maintenance procedures, which are important for proper device use. However, the absence of reported harm and the purely informational nature of the deficiency support a Moderate severity rating.

Plain-English summary

CareFusion 2200 Inc is recalling the V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS (Model F-5010, UDI/DI 10885403041020). The recall affects 11 units. This is a surgical forceps used in neuro and spine procedures.

The company determined that the Instructions for Use (IFU) provided by CareFusion was missing certain content that should have been included. The missing information relates to the interface with the device power supply and instructions for cleaning and maintenance.

The recalled units were distributed nationwide and to the following countries: Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

Users should obtain and review the complete and corrected V. Mueller Bipolar Forcep IFU from the manufacturer to ensure they have all necessary instructions for the device.

The recalled product

Product
CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • missing-maintenance-information
  • missing-power-supply-guidance

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 10885403041020
  • ALL LOTS

Distribution

Distributed nationwide across the United States.