Bipolar forceps recall for incomplete operating and maintenance instructions
Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical 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 recall with missing critical cleaning and maintenance instructions for a reusable surgical instrument. While no injuries have been reported, incomplete sterilization and maintenance instructions for surgical forceps constitute a risk-of-harm situation where improper procedures could lead to cross-contamination or device failure.
Plain-English summary
Carefusion 2200 Inc is recalling Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS with 0.4mm tip, curved design (#7, 4-3/4" overall length, reference F-3007). A total of 27 units were distributed nationwide and internationally, including to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
The FDA issued a Class II recall after determining that the Instructions for Use (IFU) provided by BD are incomplete. The missing content includes information about the interface with the device's power supply and cleaning and maintenance instructions. Users should refer to the updated V. Mueller Bipolar Forceps IFU for complete operating and maintenance guidance.
Healthcare facilities and users should ensure they have access to the complete Instructions for Use and follow all cleaning and maintenance procedures to ensure proper operation and sterilization of this surgical instrument.
The recalled product
- Product
- Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- missing-cleaning-maintenance-info
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 10885403040955
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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