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.
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: 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
- Hazard
- Affected units
- 79
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.
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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