Bipolar Forceps Recalled for Incomplete Instructions for Use
Carefusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing critical content on power supply interface and maintenance procedures. Distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 surgical instrument with incomplete Instructions for Use missing critical operational and maintenance content. While no injuries have been reported, this represents a risk-of-harm product where the missing guidance could lead to improper device operation or inadequate cleaning and maintenance in a medical setting.
Plain-English summary
The Carefusion V. Mueller GERALD BIPOLAR FORCEPS (1.0MM wide tip, 7" overall length, Reference F-1110, UDI/DI 10885403040771) are being recalled for incomplete Instructions for Use, affecting all manufactured lots of this product.
The manufacturer-provided Instructions for Use is missing critical content related to the device power supply interface and cleaning and maintenance instructions for the forceps. This missing information is necessary for proper operation and maintenance of the surgical instrument.
The product was distributed nationwide in the United States and internationally in Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
Users should contact Carefusion 2200 Inc to obtain the complete Instructions for Use documentation. Refer to the corrected V. Mueller Bipolar Forcep IFU provided by the manufacturer for complete information on device operation, cleaning, and maintenance procedures.
The recalled product
- Product
- Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 25
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 10885403040771
- 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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