CareFusion Bipolar Forceps Recalled Due to Missing Instructions for Use
CareFusion V. Mueller bipolar forceps are being recalled because the provided Instructions for Use are missing critical content about power supply interface and cleaning/maintenance. The complete information is available in the manufacturer's full IFU.
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 medical device with missing critical instructions for power supply interface and cleaning/maintenance. Although no illnesses or injuries have been reported, incomplete instructions for a surgical device constitute a risk-of-harm situation.
Plain-English summary
CareFusion 2200 Inc. is recalling the CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS (1.0MM tip, straight, 8-3/4" overall length, reference number F-5126, UDI/DI 10885403041228) across all lots. The company determined that the Instructions for Use (IFU) provided are missing certain required content that is contained in the manufacturer's complete IFU.
The missing content pertains to the device's interface with the power supply and cleaning and maintenance instructions.
The recalled device was distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. A total of 28 units were affected.
Care facilities and healthcare providers who have received this device should reference the complete V. Mueller Bipolar Forceps Instructions for Use to obtain the complete information about power supply interface and cleaning/maintenance.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- improper-use-risk
- improper-sterilization-risk
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 10885403041228
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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