Recall Z-2412-2023— Medtronic Neurosurgery

Name: FDA recall Z-2412-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-28

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2023-06-28. It names one FDA 510(k) clearance: K984053. Product: 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.

Recalling firm: Medtronic Neurosurgery
Classification: Class II
Status: Ongoing
Initiated: 2023-06-28
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K984053 — BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMedtronic PS Medical·cleared 1999-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.