Bipolar forceps recalled for incomplete instructions for use
Carefusion recalled certain bipolar forceps due to incomplete Instructions For Use. The IFU was missing content about the device's power supply interface and cleaning and maintenance 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: FDA Class II recall with no reported illnesses or injuries. The issue is incomplete documentation rather than a defective product. With no reported harm and a theoretical hazard only, this qualifies as a precautionary recall.
Plain-English summary
The recall involves 57 units of Carefusion V. Mueller Gerald Bayonet Bipolar Forceps with a 1.0mm tip and 7-1/2" overall length (reference F-1111).
The instructions for use provided with the device contain incomplete information. Specifically, the IFU is missing content related to the device's interface with the power supply and instructions for cleaning and maintenance. Correct and complete IFU documentation has been made available.
The affected devices were distributed nationwide and internationally to countries including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots of the device (UDI/DI 10885403040788) are included in this recall.
Healthcare providers and facilities that use this device should obtain the complete Instructions For Use and refer to it for proper operation, power supply connection, and cleaning and maintenance procedures.
The recalled product
- Product
- Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111
- 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 10885403040788
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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