The Recall Desk
ModerateFDA (Devices)·Z-0398-2023·Announced 2022-12-14

CareFusion Bipolar Surgical Forceps Recalled by FDA Class II Voluntary Action

CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 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 voluntary, firm-initiated FDA Class II device recall with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (Score 2).

Plain-English summary

CareFusion 2200 Inc has initiated a voluntary recall of titanium round-handle bayonet bipolar forceps (Reference F-5008) with UDI/DI 10885403041013. The recall encompasses all lots of this product.

The recalled product consists of 4 units that have been distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.

The specific reason for the recall was not disclosed in publicly available information. Healthcare facilities and surgical centers using this instrument should contact CareFusion 2200 Inc to determine if they have received affected units and to arrange for return or replacement.

The recalled product

Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • malfunction

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 10885403041013
  • ALL LOTS

Distribution

Distributed nationwide across the United States.

Related recalls

Same category