The Recall Desk
HighFDA (Devices)·Z-0408-2023·Announced 2022-12-14

Bipolar Forceps Recalled for Incomplete Instructions for Use

CareFusion bipolar forceps recalled nationwide due to incomplete Instructions for Use missing power supply interface and cleaning information. The missing content could affect proper device operation and maintenance.

What this means for you

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 of a medical device with incomplete Instructions for Use related to critical functions (power supply interface and cleaning/maintenance). While no illnesses or injuries have been reported, the missing instructions create a risk of harm through improper use or maintenance of a surgical instrument.

Plain-English summary

CareFusion 2200 Inc is recalling its V. Mueller Titanium Bayonet Bipolar Forceps (REF F-5124) due to incomplete Instructions for Use (IFU). The IFU provided by CareFusion/BD is missing content that is contained in the manufacturer's original IFU, specifically information about the interface with the device power supply and cleaning and maintenance instructions.

This Class II recall affects 21 units distributed nationwide and internationally, including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. The product is identified by UDI/DI 10885403041204, and all lots are affected.

Without complete instructions, users may not properly connect the device to the power supply or may not follow correct cleaning and maintenance procedures. This could affect device performance and safety during surgical use.

Customers who have received this product should obtain the corrected Instructions for Use from the manufacturer. Consult the attached V. Mueller Bipolar Forcep IFU for complete information on power supply interface and cleaning and maintenance instructions.

The recalled product

Product
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
21

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 10885403041204
  • 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 →

Related recalls

Same manufacturer · Carefusion 2200 Inc

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