Surgical Bipolar Forceps Recalled for Missing Instructions
Carefusion is recalling the V. Mueller Bipolar Forceps Insulated due to missing instructions for power supply interface and cleaning/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: Class II recall for missing safety-critical instructions on surgical forceps; missing guidance on power supply interface and maintenance represents risk of harm despite no reported incidents.
Plain-English summary
Carefusion 2200 Inc. is recalling the V. Mueller GERALD Bipolar Forceps Insulated (1.0MM tip, 7 inch overall length, reference F-1112) due to incomplete Instructions for Use (IFU). The FDA identified that the provided IFU was missing certain content from the manufacturer's original instructions.
The missing content relates specifically to the interface with the device power supply and cleaning and maintenance procedures. These instructions are necessary for proper device operation and maintenance.
The recalled forceps were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. All lots with UDI/DI 10885403040795 are affected by this recall.
Carefusion has provided a corrected V. Mueller Bipolar Forceps IFU with the missing content. Users should consult this updated IFU for complete instructions on power supply interface and maintenance procedures.
The recalled product
- Product
- Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
- 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 10885403040795
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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