CareFusion Bipolar Forceps Recalled: Incomplete Instructions for Power Supply
CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving incomplete Instructions For Use. The missing information on power supply interface and maintenance procedures is important for safe device operation. No illnesses or injuries have been reported.
Plain-English summary
CareFusion is recalling V. Mueller bipolar forceps due to incomplete instructions for use. The affected device is the TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS with a 1.5mm tip, overall length 10.5 inches (REF F-5022). The recall involves 32 units.
The Instructions For Use (IFU) provided by the manufacturer is missing critical information. Specifically, it lacks content regarding the interface with the device power supply and procedures for cleaning and maintenance. This information is necessary for safe and proper operation of the surgical instrument.
The affected devices were distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots of the product are included in the recall (UDI/DI 10885403041075).
The corrected V. Mueller bipolar forceps Instructions For Use contains the complete information regarding power supply interface and proper cleaning and maintenance procedures.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 32
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 10885403041075
- ALL LOTS
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 45 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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