Bipolar Forceps Recall: Incomplete Instructions for Surgical Device
BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.
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 recall involving incomplete Instructions For Use for a surgical device. While no illnesses or injuries have been reported, the missing information about power supply interface and maintenance procedures represents a risk of harm if the device is used or maintained improperly.
Plain-English summary
CareFusion 2200 Inc. is recalling the CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS, Reference F-5301. The Instructions For Use (IFU) provided with the device is incomplete—it is missing certain content found in the manufacturer's complete IFU, specifically instructions related to the interface with the device power supply and procedures for cleaning and maintenance.
Approximately 201 units with UDI/DI 10885403041266 have been distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. All lots are affected.
Facilities and users who possess this device should obtain and review the complete V. Mueller Bipolar Forceps IFU, which includes the missing instructions on power supply interface and device maintenance. For questions or to obtain the complete IFU, contact CareFusion 2200 Inc.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- labeling-deficiency
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 10885403041266
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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