Carefusion Bipolar Forceps Recalled Due to Missing Instructions for Use
Carefusion is recalling 347 units of SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS due to incomplete Instructions for Use. The missing content covers power supply interface 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: This is a Class II FDA recall for incomplete Instructions for Use on a medical device. The missing content covers critical operational and maintenance information, creating a risk of harm. No illnesses or injuries have been reported. This meets the rubric criterion for a risk-of-harm product without reported injury.
Plain-English summary
Carefusion 2200 Inc is recalling 347 units of its Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS (1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4", REF F-1003) due to incomplete Instructions for Use (IFU).
The IFU provided by the manufacturer is missing critical information regarding the interface with the device power supply and cleaning and maintenance instructions. This missing content could affect the safe and effective operation of the forceps.
The recalled forceps were distributed nationwide as well as internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are included in this recall, identified by UDI/DI 10885403040726.
The recalled product
- Product
- Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- missing-maintenance-procedures
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 10885403040726
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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