Surgical Bipolar Forceps Recalled Due to Incomplete Instructions for Use
Carefusion recalls V. Mueller bipolar forceps with incomplete instructions. The device lacks critical information on power supply interface and cleaning 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 device with incomplete Instructions For Use for critical functions including power supply interface and cleaning/maintenance procedures. Missing safety information creates risk of improper use and maintenance, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS (Model F-1301, 1.0MM tip, 7-1/2 inches overall length). Nine units have been distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
The Instructions For Use (IFU) provided with the device are incomplete. The missing information relates to the interface with the device power supply and procedures for cleaning and maintenance. The manufacturer's complete IFU contains critical content not included in the provided documentation.
Users of this device should immediately refer to the attached manufacturer's complete V. Mueller Bipolar Forcep IFU for all information on power supply interface and maintenance procedures. The complete instructions must be consulted before use and for proper ongoing maintenance and sterilization of the device.
The recalled product
- Product
- Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
- 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 10885403040825
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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