Bipolar Forceps Recalled for Missing Instructions on Cleaning and Power Supply
CareFusion V. Mueller bipolar forceps (Ref F-5073) recalled due to missing critical instructions for power supply interface and cleaning and maintenance procedures. Users should obtain the complete Instructions For Use from the manufacturer.
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 surgical device with missing critical instructions for sterilization procedures and power supply interface. While no illnesses or injuries have been reported, incomplete user guidance on sterilization and device operation for a surgical instrument presents a theoretical risk of harm.
Plain-English summary
CareFusion has recalled the V. Mueller Round Handle Bayonet Bipolar Forceps (Reference F-5073, 1.5mm tip, 10.5 inches in length). Thirty units have been distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.
The recall was issued because the Instructions For Use (IFU) provided with the device is missing critical content that is contained in the manufacturer's complete IFU. Specifically, the missing instructions relate to the interface with the device power supply and proper cleaning and maintenance procedures.
Users of affected units should obtain the complete and corrected Instructions For Use from CareFusion and ensure all personnel are aware of the complete guidance on device use, cleaning, and maintenance before the device is placed into service.
The recalled product
- Product
- CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5073
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
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 10885403041198
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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