Surgical Bipolar Forceps Recall: Incomplete Instructions for Use
Carefusion is recalling 218 units of surgical bipolar forceps due to incomplete product instructions. The Instructions For Use is missing information about power supply interface and cleaning/maintenance procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II surgical device recall due to incomplete Instructions For Use covering power supply interface and cleaning/maintenance procedures. While no illnesses or injuries have been reported, the incomplete documentation poses a risk of harm in a surgical context where proper device preparation is essential.
Plain-English summary
Carefusion 2200 Inc is recalling 218 units of the V. Mueller Hardy Bayonet Bipolar Forceps with Stop (0.5mm tip, 8.5-inch length, Reference F-1030). The device was distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand under UDI/DI 10885403040733. The recall covers all manufacturing lots.
The Instructions For Use (IFU) provided by Carefusion is missing content that is contained in the manufacturer's complete IFU. The missing information relates to the interface with the device power supply and cleaning and maintenance instructions. Healthcare providers using this device without access to the complete IFU may lack critical guidance for proper device operation and maintenance.
A corrected Instructions For Use has been made available by Carefusion. Healthcare facilities and medical professionals should obtain the complete IFU, which contains the missing information on power supply interface and cleaning and maintenance procedures. Contact Carefusion 2200 Inc if a corrected IFU was not received.
The recalled product
- Product
- Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 218
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 10885403040733
- 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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