The Recall Desk
HighFDA (Devices)·Z-0397-2023·Announced 2022-12-14

Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

CareFusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing power supply interface and maintenance guidance.

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 medical device with missing critical maintenance and power supply interface instructions. This is a risk-of-harm product (surgical forceps) where incomplete guidance could lead to improper device operation or malfunction during procedures, though no patient incidents have been reported.

Plain-English summary

The CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS (REF F-5006) are being recalled because the manufacturer's Instructions for Use (IFU) provided by the company is incomplete. The missing information relates to the device's interface with the power supply and does not include proper cleaning and maintenance instructions.

These bipolar forceps are surgical instruments used in spine procedures. When Instructions for Use are incomplete or missing critical safety information, there is a risk that the device may not be operated, cleaned, or maintained correctly, potentially affecting its performance and safety during surgical use.

The recall affects all lots of this device, identified by UDI/DI 10885403041006. The devices were distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.

Healthcare providers and surgical facilities that have this device should obtain the complete and correct Instructions for Use from CareFusion 2200 Inc. If you have questions or suspect an issue with this device, report it to FDA's MedWatch program at www.fda.gov/medwatch.

The recalled product

Product
CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard
  • incomplete-instructions
  • missing-maintenance-info

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 10885403041006
  • ALL LOTS

Distribution

Distributed nationwide across the United States.

Related recalls

Same category