The Recall Desk
ModerateFDA (Devices)·Z-0396-2023·Announced 2022-12-14

CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

CareFusion bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning 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: FDA Class II recall for incomplete documentation. Missing instructions address power supply interface and maintenance procedures, but no illnesses or injuries have been reported. This fits criteria for minor labeling errors and precautionary recalls.

Plain-English summary

CareFusion V. Mueller Titanium Round Handle Bayonet Bipolar Forceps (Model F-5002) are being recalled due to incomplete instructions for use.

The manufacturer determined that the instructions provided with the device lack content related to the interface with the device power supply, as well as cleaning and maintenance instructions. The recall affects 15 units distributed nationwide and internationally.

Healthcare facilities and individuals with this device should obtain the complete manufacturer instructions for use before further use. The updated instructions provide guidance on proper power supply interfacing and appropriate device maintenance and cleaning procedures. No illnesses or injuries have been reported in association with this recall.

The recalled product

Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
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 10885403040986
  • ALL LOTS

Distribution

Distributed nationwide across the United States.