The Recall Desk
ModerateFDA (Devices)·Z-0392-2023·Announced 2022-12-14

Carefusion Bipolar Forceps Recalled for Incomplete Instructions for Use

Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.

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 voluntary precautionary recall for incomplete Instructions for Use. No adverse events or injuries have been reported. The missing content addresses power supply interface and cleaning/maintenance information, which are important for safe operation, but the lack of reported or imminent harm classifies this as a documentation deficiency.

Plain-English summary

Carefusion 2200 Inc is recalling the V. Mueller Jewelers Bipolar Forceps (REF F-3000) because the Instructions for Use (IFU) provided is missing important content from the manufacturer's IFU. Specifically, the missing content relates to the interface with the device's power supply and cleaning and maintenance instructions.

The affected devices include all lots of the product with UDI/DI 10885403040924. A total of 236 units have been distributed nationwide and to multiple international locations including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

Healthcare facilities and users of this device should obtain the corrected V. Mueller Bipolar Forcep Instructions for Use, which contains the complete content including power supply interface information and proper cleaning and maintenance procedures. Contact Carefusion for the complete corrected instructions.

The recalled product

Product
Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • electrical-safety
  • maintenance-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 10885403040924
  • ALL LOTS

Distribution

Distributed nationwide across the United States.