Bipolar Forceps Recall: Missing Power Supply and Cleaning Instructions
Carefusion is recalling bipolar forceps due to incomplete Instructions for Use. The IFU is missing content about 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 a labeling and documentation issue involving incomplete Instructions for Use with no reported illnesses or injuries. The hazard is theoretical—proper instructions can be obtained from the manufacturer—making it consistent with FDA Class II recalls involving missing or incomplete instructional content.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller Titanium Bayonet Bipolar Forceps (Model F-5127) due to incomplete Instructions for Use (IFU). The manufacturer's original IFU contains important information that has not been included in the version provided by BD.
The missing content relates to the interface between the forceps and the device power supply, as well as cleaning and maintenance instructions. Without this information, users may not properly maintain or interface the device with its power supply.
This recall affects all lots of the product with UDI/DI 10885403041235. The affected units have been distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.
If you have this product, contact Carefusion 2200 Inc to obtain the complete manufacturer's Instructions for Use. Do not use the device until you have reviewed the complete instructions.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 5
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 10885403041235
- 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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