Bipolar Forceps Recall: Missing Device Power Supply and Maintenance Instructions
Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 for incomplete device instructions. Missing power supply interface and maintenance guidance constitutes a documentation deficiency without reported injuries or adverse events.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller Cushing Bayonet Bipolar Forceps (model F-1300) nationwide and internationally. This is a Class II recall.
The Instructions for Use (IFU) provided by the manufacturer are incomplete. The missing information relates to the interface with the device's power supply as well as cleaning and maintenance procedures. The corrected IFU is available from the manufacturer.
Approximately 146 units have been distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.
No injuries or illnesses have been reported. Affected hospitals and medical facilities should contact Carefusion for the complete instructions and ensure staff review the corrected IFU before using the device.
The recalled product
- Product
- Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 146
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 10885403040818
- 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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