Surgical Bipolar Forceps Recalled for Missing Safety Instructions
Carefusion is recalling surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for incomplete instructions on a surgical device. Missing safety-critical information about power supply interface and maintenance procedures represents a risk of improper use, though no injuries have been reported.
Plain-English summary
Carefusion 2200 Inc is recalling Carefusion V. Mueller ADSON BIPOLAR FORCEPS (Model F-3010) due to incomplete instructions for use. The recall involves 1,063 units with UDI/DI 10885403040962.
The instructions provided are missing critical content related to the interface with the device power supply and cleaning and maintenance instructions. This missing information could affect proper use and maintenance of the device.
The recalled forceps were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. Healthcare facilities and users of these devices should review the manufacturer's complete instructions for use.
Users should ensure they have access to the complete Instructions for Use (IFU) from V. Mueller that includes information on power supply interface and cleaning and maintenance procedures before using the device.
The recalled product
- Product
- Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1,063
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 10885403040962
- 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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