The Recall Desk
ModerateFDA (Devices)·Z-0384-2023·Announced 2022-12-14

Bipolar Forceps Recall: Missing Device Power Supply and Maintenance Instructions

Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.

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 device instructions. Missing power supply interface and maintenance guidance constitutes a documentation deficiency without reported injuries or adverse events.

Plain-English summary

Carefusion 2200 Inc is recalling the V. Mueller Cushing Bayonet Bipolar Forceps (model F-1300) nationwide and internationally. This is a Class II recall.

The Instructions for Use (IFU) provided by the manufacturer are incomplete. The missing information relates to the interface with the device's power supply as well as cleaning and maintenance procedures. The corrected IFU is available from the manufacturer.

Approximately 146 units have been distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.

No injuries or illnesses have been reported. Affected hospitals and medical facilities should contact Carefusion for the complete instructions and ensure staff review the corrected IFU before using the device.

The recalled product

Product
Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • mis-labeling

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 10885403040818
  • ALL LOTS

Distribution

Distributed nationwide across the United States.