Agency classClass IIOur severity:High FDA (Devices)·Z-0401-2023·Announced 2022-12-14

Bipolar Forceps Recall: Missing Device Use and Maintenance Instructions

CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/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: FDA Class II recall involving incomplete Instructions for Use for a surgical device. The missing documentation covers critical use procedures (power supply interface) and maintenance instructions, creating potential risk of improper operation. No injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 2200 Inc is recalling the V. Mueller Titanium Round Handle Bayonet Bipolar Forceps (Model F-5016, UDI/DI 10885403041051) nationwide and internationally. The Instructions for Use provided by the manufacturer are incomplete and missing critical information related to the device's power supply interface and cleaning and maintenance procedures.

The missing documentation may prevent users from properly understanding how to operate the device safely and maintain it according to manufacturer specifications. Affected units were distributed nationwide and in Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

Healthcare facilities and users of this device should refer to the corrected V. Mueller Bipolar Forceps Instructions for Use, which contains the complete information on power supply interface and cleaning and maintenance instructions. No injuries or adverse events have been reported to date.

The recalled product

Product: CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
Manufacturer: Carefusion 2200 Inc
Category: Medical Device — Surgical Instrument
Hazard: incomplete-instructions
missing-maintenance-guidance
Affected units: 25

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 10885403041051
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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Same hazard · incomplete instructions