Bipolar Forceps Device Incomplete Instructions for Use Recalled
CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with incomplete Instructions for Use containing safety information about device power supply interface and cleaning. No illnesses or injuries reported; the recall is precautionary and based on documentation deficiency.
Plain-English summary
CareFusion V. Mueller bipolar forceps with 1.0mm tip (reference number F-5061) are being recalled. The recalled devices include 35 units with UDI/DI 10885403041136. The devices were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.
The recall was issued because the Instructions for Use (IFU) provided by the manufacturer contained missing information. This missing content relates to the device's interface with the power supply, as well as cleaning and maintenance instructions.
Users should obtain and refer to the corrected V. Mueller Bipolar Forceps Instructions for Use. Complete instructions covering device power supply interface and cleaning and maintenance procedures have been provided as part of this recall notification.
The recalled product
- Product
- CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 35
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 10885403041136
- 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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