Bipolar Forceps Recall Due to Incomplete Instructions for Use
Carefusion is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface 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 for incomplete Instructions for Use on a surgical device. No illnesses or injuries have been reported. The rubric classifies documentation issues as Moderate when no incidents have occurred.
Plain-English summary
Carefusion 2200 Inc is recalling 259 units of the V. Mueller GERALD BAYONET BIPOLAR FORCEPS with a 1.0MM tip, which are surgical instruments used in operating rooms.
The recall is issued because the Instructions for Use provided by Carefusion are incomplete. Specifically, the instructions are missing content related to the interface between the device and its power supply, as well as proper cleaning and maintenance procedures. A corrected version of the Instructions for Use has been issued by the manufacturer.
The affected devices were distributed nationwide and to international locations including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. Healthcare facilities and professionals who possess these forceps should consult the corrected Instructions for Use to ensure proper use, maintenance, and cleaning.
The recalled product
- Product
- Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- improper-maintenance
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 10885403040801
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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