The Recall Desk
ModerateFDA (Devices)·Z-0388-2023·Announced 2022-12-14

Bipolar Irrigating Forceps Recall: Missing Power Supply and Maintenance Instructions

Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.

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 instructional content (documentation deficiency) with no reported illnesses, injuries, or adverse events. It addresses missing maintenance and interface information rather than a manufacturing defect or safety hazard with reported harm.

Plain-English summary

Carefusion 2200 Inc is recalling 132 units of V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED (REF F-1305) that were distributed nationwide and internationally, including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

The recall was initiated because the Instructions For Use (IFU) provided with the device are incomplete. The manuals are missing critical information regarding the interface with the device power supply and instructions for proper cleaning and maintenance of the forceps.

A corrected and complete version of the Instructions For Use has been prepared that includes all previously missing content. Users who have these devices should obtain the corrected instructions to ensure they have complete information about device setup and maintenance.

The recalled product

Product
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions
  • maintenance-documentation

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 10885403040856
  • ALL LOTS

Distribution

Distributed nationwide across the United States.