Bipolar Irrigating Forceps Recall: Missing Power Supply and Maintenance Instructions
Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.
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 recall for incomplete instructional content (documentation deficiency) with no reported illnesses, injuries, or adverse events. It addresses missing maintenance and interface information rather than a manufacturing defect or safety hazard with reported harm.
Plain-English summary
Carefusion 2200 Inc is recalling 132 units of V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED (REF F-1305) that were distributed nationwide and internationally, including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
The recall was initiated because the Instructions For Use (IFU) provided with the device are incomplete. The manuals are missing critical information regarding the interface with the device power supply and instructions for proper cleaning and maintenance of the forceps.
A corrected and complete version of the Instructions For Use has been prepared that includes all previously missing content. Users who have these devices should obtain the corrected instructions to ensure they have complete information about device setup and maintenance.
The recalled product
- Product
- Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 132
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 10885403040856
- 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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