Carefusion Bipolar Forceps Recalled Due to Incomplete Instructions
Carefusion recalled 84 units of HARDY-STYLE BAYONET BIPOLAR FORCEPS nationwide and internationally due to incomplete Instructions for Use. The distributed documentation is missing information about power supply interface, cleaning, and maintenance procedures.
What this means for you
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 with incomplete device documentation. No illnesses or injuries have been reported. The missing instructions for use—specifically regarding power supply interface and maintenance procedures—constitute a risk-of-harm situation where proper device use and maintenance may be compromised.
Plain-English summary
Carefusion 2200 Inc is recalling 84 units of V. Mueller HARDY-STYLE BAYONET BIPOLAR FORCEPS with 0.5MM tip (Reference F-1035, UDI/DI 10885403040740, all lots) due to incomplete Instructions for Use.
The Instructions for Use provided by Carefusion is missing critical content that appears in the manufacturer's full instructions. Specifically, the distributed documentation lacks information about the interface with the device power supply, as well as cleaning and maintenance instructions.
The recalled units were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. Users of this device should contact Carefusion for the complete Instructions for Use that includes the missing power supply interface and maintenance information.
The recalled product
- Product
- Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- missing-instructions
- incomplete-documentation
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 10885403040740
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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