Surgical Bipolar Forceps Recalled Due to Missing Operating and Maintenance Instructions
CareFusion is recalling 1369 units of V. Mueller bipolar surgical forceps (Model F-1000) due to incomplete instructions for use. The provided instructions lack information about power supply interface and cleaning and 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: This is an FDA Class II recall for incomplete instructions on a powered surgical device. Although no injuries or illnesses have been reported, missing information about power supply interface and maintenance procedures represents a risk-of-harm situation for proper device operation during surgical procedures.
Plain-English summary
CareFusion 2200 Inc is recalling 1369 units of V. Mueller Cushing Bayonet Bipolar Insulated Forceps (0.7mm tip, 7.5 inches long, Model F-1000) due to incomplete instructions for use.
The manufacturer determined that the instructions provided are missing content from the complete manufacturer instructions for use. Specifically, the provided instructions lack information about the interface with the device power supply, as well as cleaning and maintenance procedures. This information is contained in the complete manufacturer's instructions for use referenced in this recall notice.
The affected forceps were distributed nationwide and to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are affected, identified by UDI/DI 10885403040702.
The FDA classification for this recall is Class II. Complete manufacturer instructions for use should be consulted to ensure proper operation, maintenance, and cleaning of this surgical device.
The recalled product
- Product
- CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1,369
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 10885403040702
- 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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