CareFusion Bipolar Surgical Forceps Recalled for Incomplete Operating Instructions
CareFusion bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.
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 medical device recall involving missing documentation in the Instructions for Use. Although the issue concerns device operation and maintenance, no adverse events or injuries have been reported. The recall is precautionary in nature, correctable by providing complete instructions.
Plain-English summary
CareFusion 2200 Inc is recalling the CareFusion V. Mueller Cushing Micro Bipolar Forceps (reference F-52000) because the provided Instructions for Use documentation was incomplete. The IFU was missing information about the device's interface with the power supply and procedures for cleaning and maintenance. The recall affects all lots of the device, with 239 units distributed in the United States, Canada, Austria, Germany, Hong Kong, Israel, Egypt, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
A corrected and complete Instructions for Use document is available that includes all necessary information on power supply interface and cleaning and maintenance procedures.
The recalled product
- Product
- CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000
- 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 10885403041297
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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