Bipolar Surgical Forceps Recalled Due to Missing Instructions for Use
CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to 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: This is a Class II FDA medical device recall involving missing operational and cleaning instructions for a surgical instrument. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
CareFusion 2200 Inc is recalling the V. Mueller Neuro/Spine titanium bayonet insulated irrigating bipolar forceps, model F-5304. This surgical instrument was distributed nationwide and to multiple countries including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
The recall was initiated because the originally provided Instructions for Use (IFU) contained missing information. Specifically, the IFU did not include content relating to the interface between the device and its power supply, nor did it contain the required cleaning and maintenance instructions.
The manufacturer has provided a corrected and complete V. Mueller Bipolar Forcep IFU. Healthcare facilities and medical professionals who have received this device should obtain and review the complete instructions before continued use.
The recalled product
- Product
- CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
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 10885403041297
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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