CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use
CareFusion is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Class II recall is primarily a documentation deficiency with no reported injuries or illnesses. The missing IFU content covers power supply interface and cleaning/maintenance procedures, which are important for proper device use. However, the absence of reported harm and the purely informational nature of the deficiency support a Moderate severity rating.
Plain-English summary
CareFusion 2200 Inc is recalling the V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS (Model F-5010, UDI/DI 10885403041020). The recall affects 11 units. This is a surgical forceps used in neuro and spine procedures.
The company determined that the Instructions for Use (IFU) provided by CareFusion was missing certain content that should have been included. The missing information relates to the interface with the device power supply and instructions for cleaning and maintenance.
The recalled units were distributed nationwide and to the following countries: Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
Users should obtain and review the complete and corrected V. Mueller Bipolar Forcep IFU from the manufacturer to ensure they have all necessary instructions for the device.
The recalled product
- Product
- CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 11
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 10885403041020
- ALL LOTS
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 45 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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