Z-2412-2023 Class II Ongoing
FDA device recall Z-2412-2023 was initiated by Medtronic Neurosurgery on June 28, 2023 and is designated Class II. Reason for recall: Product labeling contains incorrect expiration date The recall status is ongoing. Affected quantity: 44 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2023
- Initiation Date
- June 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units
Product Description
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Reason for Recall
Product labeling contains incorrect expiration date
Distribution Pattern
US Nationwide distribution in the states of NJ, FL, CA, IL.
Code Information
Lot # 226632942; UDI-DI: 00763000624781