Carefusion Bipolar Surgical Forceps Recalled for Missing Instructions
Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface 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 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: This is an FDA Class II medical device recall involving incomplete instructions for use, with no reported injuries or illnesses. The missing content concerns power supply interface and maintenance procedures, constituting a documentation deficiency rather than a physical device hazard.
Plain-English summary
Carefusion 2200 Inc. is recalling the Hardy Bayonet Irrigating Bipolar Forceps Insulated, REF F-1335. The recall is due to incomplete instructions for use (IFU). The IFU provided was missing critical content related to the interface between the device and its power supply, as well as cleaning and maintenance instructions.
According to the FDA, 41 units of this device have been distributed within the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All affected units carry the UDI/DI 10885403040870.
Carefusion has prepared a complete version of the V. Mueller Bipolar Forceps Instructions for Use that includes all necessary information about power supply interface and maintenance procedures. Users and healthcare facilities should obtain and review the complete instructions before continued use of the device.
The recalled product
- Product
- Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- Affected units
- 41
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 10885403040870
- 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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