Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI
Summary
The FDA issued a Class II for Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Inje by Medtronic Neurosurgery. Reason: Product labeling contains incorrect expiration date.
Details
Source
Device Recall
External ID
Z-2412-2023
Action Date
2023-08-23
Status
Ongoing
Category
device
Product Description
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Lot/Code Info: Lot # 226632942; UDI-DI: 00763000624781
Quantity Affected: 44 units
Reason for Recall
Product labeling contains incorrect expiration date
Distribution
US Nationwide distribution in the states of NJ, FL, CA, IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-28
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neurosurgery) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neurosurgery have FDA actions?
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2412-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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