The Recall Desk
ModerateFDA (Devices)·Z-0412-2023·Announced 2022-12-14

Bipolar Surgical Forceps Recalled for Missing Instruction Manual Content

CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.

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 Instructions for Use documentation. No illnesses or injuries reported. The hazard is documentation-related rather than a product defect, consistent with minor labeling errors and compliance issues.

Plain-English summary

CareFusion V. Mueller Neuro/Spine Titanium Bipolar Forceps (Reference F-5128) has been recalled. The recall involves 79 units distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

CareFusion determined that its provided Instructions for Use are missing content related to the device's power supply interface and cleaning and maintenance procedures. A corrected version of the Instructions for Use is available.

Healthcare providers should obtain and review the corrected Instructions for Use, particularly for the power supply interface and proper cleaning and maintenance guidance.

The recalled product

Product
CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard
  • mis-labeling
  • improper-use

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 10885403041242
  • ALL LOTS

Distribution

Distributed nationwide across the United States.

Related recalls

Same category