Carefusion Bipolar Forceps Recalled for Incomplete Instructions for Use
BD is recalling Carefusion V. Mueller Bipolar Forceps due to incomplete Instructions for Use lacking critical content about 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: This is a Class II FDA recall for incomplete instructions on surgical equipment. While no illnesses or injuries have been reported, missing cleaning and maintenance procedures on surgical instruments presents a risk of harm through potential inadequate sterilization.
Plain-English summary
Carefusion 2200 Inc, through BD, is recalling the V. Mueller CUSHING BIPOLAR FORCEPS (1.5MM tip, 7 inches overall length, Reference F-2002) due to incomplete Instructions for Use.
The Instructions for Use provided by BD is missing certain content that is contained in the manufacturer's IFU. Specifically, the missing content relates to the interface with the device power supply as well as cleaning and maintenance instructions.
The recall affects 128 units distributed nationwide and internationally, including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are affected (UDI/DI 10885403040900).
Affected facilities should obtain and refer to the corrected V. Mueller Bipolar Forcep Instructions for Use provided by the manufacturer. Healthcare providers and facilities should review the complete IFU to ensure proper use, power supply interface management, and appropriate cleaning and maintenance procedures.
The recalled product
- Product
- Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- missing-maintenance-guidance
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 10885403040900
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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