Z-0393-2023 Class II Ongoing
FDA device recall Z-0393-2023 was initiated by Carefusion 2200 Inc on November 2, 2022 and is designated Class II. Reason for recall: 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 d… The recall status is ongoing. Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- November 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
Reason for Recall
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.
Distribution Pattern
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
Code Information
UDI/DI 10885403040955, ALL LOTS