Bipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions
Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.
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: FDA Class II recall of a surgical instrument with missing critical instructions for power supply interface and maintenance/cleaning. No reported injuries; per the rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
Carefusion 2200 Inc is recalling 203 units of its V. Mueller SEMKIN Bipolar Forceps (REF F-1040) distributed nationwide and internationally. The device is a 5-1/2" surgical instrument with a 0.7MM tip, identified by UDI/DI 10885403040757.
The company determined that the Instructions for Use provided with the device are incomplete. The IFU lacks critical content related to the interface with the device power supply and cleaning and maintenance instructions.
This recall affects devices distributed in the United States, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
Users should contact Carefusion 2200 Inc for updated Instructions for Use that include the missing information on power supply interface and maintenance and cleaning procedures.
The recalled product
- Product
- Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 203
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 10885403040757
- 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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