CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use
CareFusion 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.
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 Class II medical device recall involves missing instructional content critical to safe operation and maintenance. The incomplete IFU regarding power supply interface and cleaning/maintenance procedures poses a risk of improper use and inadequate sterilization, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 2200 Inc is recalling 4,557 units of the V. Mueller ADSON Bipolar Forceps (REF F-3015) due to incomplete Instructions for Use. The IFU is missing content related to the interface with the device power supply and cleaning and maintenance instructions.
The affected product is a surgical bipolar forceps with a 1.0mm tip and 4-3/4 inches overall length. Distribution includes the nationwide market as well as Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are affected, identified by UDI/DI 10885403040979.
Customers who have this device should contact CareFusion 2200 Inc for the corrected Instructions for Use before further use. The manufacturer is providing updated instructions that include the previously missing content on power supply interface and maintenance procedures.
The recalled product
- Product
- CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- Affected units
- 4,557
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 10885403040979
- 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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