Z-0384-2023 Class II Ongoing
FDA device recall Z-0384-2023 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: 146 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
- 146 units
Product Description
Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
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 10885403040818, ALL LOTS