Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use
Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on 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: This is an FDA Class II recall with no reported illnesses or injuries. The issue is incomplete documentation on a surgical device, constituting a labeling deficiency rather than a product malfunction. The hazard is theoretical, dependent on end-user actions regarding power interface and maintenance.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller GERALD BAYONET BIPOLAR FORCEPS (Model F-1303, 1.0MM tip, 7.5 inches overall length) due to incomplete Instructions for Use provided by the manufacturer.
The Instructions for Use distributed by Carefusion is missing critical content that is contained in the manufacturer's complete IFU. Specifically, the provided instructions lack guidance on the interface with the device power supply, as well as detailed cleaning and maintenance instructions.
This recall affects 52 units 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 production lots are included (UDI/DI 10885403040832). Healthcare providers and facilities in possession of these forceps should obtain and review the complete V. Mueller bipolar forcep instructions for use to ensure proper power supply interfacing, cleaning, and maintenance procedures.
The recalled product
- Product
- Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 52
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 10885403040832
- 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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