FDAClass IIAugust 23, 2023

Medtronic recall: Labeling Error

Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only

Why was Medtronic recalled?

Product labeling contains incorrect expiration date

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 226632942; UDI-DI: 00763000624781

Product
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Recalling firm
Medtronic Neurosurgery
Quantity
44 units
Distribution
US Nationwide distribution in the states of NJ, FL, CA, IL.
Recall date
August 23, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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