The Recall Desk
HighFDA (Devices)·Z-0374-2023·Announced 2022-12-14

Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

Carefusion is recalling 418 units of bipolar surgical forceps because the provided instructions lack critical content about power supply interface and maintenance. Complete manufacturer instructions are necessary for safe device operation.

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: Incomplete instructions for a surgical device regarding power supply interface and maintenance present a potential risk of harm if the device is used or maintained without complete guidance, though no adverse events have been reported.

Plain-English summary

Carefusion 2200 Inc is recalling 418 units of the V. Mueller Scoville-Greenwood Bayonet Bipolar Forceps (Model F-1002, 1.5mm tip, 7-3/4 inch length) across all lot numbers. The device was distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.

The Instructions for Use provided with the device is missing important content contained in the manufacturer's original instructions. Specifically, the provided documentation lacks information regarding the device's interface with the power supply and instructions for proper cleaning and maintenance. This incomplete information could prevent proper operation and maintenance of the device.

Facilities and individuals using this device should consult the complete manufacturer's Instructions for Use provided by Carefusion 2200 Inc to ensure proper operation, maintenance, and cleaning procedures are followed.

The recalled product

Product
CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
Manufacturer
Carefusion 2200 Inc
Hazard
  • incomplete-instructions

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 10885403040719
  • ALL LOTS

Distribution

Distributed nationwide across the United States.