FDA Enforcement
Class II
Ongoing
Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110
Recall: Z-0380-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0380-2023
- Event ID
- 90967
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Carefusion 2200 Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2022
- Initiation Date
- November 2, 2022
- Classification Date
- December 3, 2022
- Address
- 75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States
Description
Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110
Reason
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Code Info
UDI/DI 10885403040771, ALL LOTS
Distribution
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
Quantity
25 units