The Recall Desk
ModerateFDA (Devices)·Z-0400-2023·Announced 2022-12-14

Bipolar forceps recalled for incomplete instructions for use

Carefusion V. Mueller bipolar forceps are recalled because their instructions are missing information on power supply interface and cleaning procedures. Users should obtain the complete manufacturer instructions.

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 for incomplete Instructions for Use. No illnesses or injuries have been reported. The hazard is theoretical—based on potential misuse due to missing instructions about power supply interface and cleaning procedures—making this a precautionary labeling recall.

Plain-English summary

Carefusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS (ref. F-5014) are being recalled. The manufacturer has identified that the Instructions for Use provided contain incomplete information compared to the manufacturer's complete instructions.

The missing content includes instructions for the interface with the device power supply and procedures for cleaning and maintenance. These instructions are necessary for proper and safe use of the device.

These devices were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are affected (UDI/DI: 10885403041044). Users should obtain and review the complete V. Mueller Bipolar Forcep Instructions for Use before continuing to use the device.

The recalled product

Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014
Manufacturer
Carefusion 2200 Inc
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 10885403041044
  • ALL LOTS

Distribution

Distributed nationwide across the United States.