Surgical Bipolar Forceps Recalled for Incomplete Operating Instructions
Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning 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: FDA Class II recall for incomplete operating instructions on a surgical device. No injuries or malfunctions have been reported, but missing instructions on power supply interface and maintenance procedures could affect proper device operation and safety.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller Cushing Bayonet Bipolar Forceps (Ref F-2004, UDI 10885403040917) used in surgical procedures. The recall affects all lots of this device, totaling 1,810 units, with distribution across the United States and multiple international locations.
The Instructions for Use (IFU) provided by BD lacks critical content from the manufacturer's original IFU. Specifically, the distributed IFU is missing instructions for interfacing the device with the power supply and procedures for proper cleaning and maintenance.
Healthcare facilities and medical professionals using these forceps should immediately obtain the complete V. Mueller Bipolar Forcep IFU from the manufacturer to ensure proper power supply connection and appropriate cleaning procedures.
The recalled product
- Product
- Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1,810
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 10885403040917
- 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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