Agency classClass IIOur severity:High FDA (Devices)·Z-0405-2023·Announced 2022-12-14

Bipolar forceps Instructions for Use missing power supply and maintenance information

CareFusion bipolar forceps have incomplete Instructions for Use missing power supply interface and maintenance guidance. Users should obtain complete instructions from the manufacturer before use.

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 medical device with incomplete Instructions for Use regarding critical operational information (power supply interface and maintenance procedures) with no reported injuries or illnesses, meeting the criteria for risk-of-harm products where injury has not been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has determined that CareFusion 2200 Inc's V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS (Model F-5067, 0.7MM tip, 10-1/2 inches in length) has incomplete Instructions for Use (IFU). The manufacturer's complete IFU contains important information that was not included in the IFU distributed by CareFusion.

The missing content relates to two critical operational areas: the interface between the forceps and the device power supply, and detailed cleaning and maintenance instructions. This incomplete guidance could impact proper use and maintenance of the device.

The affected product was distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. All lots produced (UDI/DI 10885403041167) are included in this recall.

No illnesses or injuries have been reported. Users should immediately obtain complete Instructions for Use from CareFusion 2200 Inc before continued use of the device.

The recalled product

Product: CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067
Manufacturer: Carefusion 2200 Inc
Category: Medical Device
Hazard: incomplete-instructions
missing-maintenance-guidance
Affected units: 24

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 10885403041167
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.

See all 45 products in this recall →

Same manufacturer · Carefusion 2200 Inc

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