FDA Enforcement
Class II
Ongoing
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Recall: Z-2412-2023
·
Reported August 23, 2023
Enforcement
- Recall Number
- Z-2412-2023
- Event ID
- 92702
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Neurosurgery
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 23, 2023
- Initiation Date
- June 28, 2023
- Classification Date
- August 17, 2023
- Address
- 5290 California Ave, Irvine, CA, 92617-3073, United States
Description
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Reason
Product labeling contains incorrect expiration date
Code Info
Lot # 226632942; UDI-DI: 00763000624781
Distribution
US Nationwide distribution in the states of NJ, FL, CA, IL.
Quantity
44 units