Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI

FDA device recall Z-2412-2023 · posted 2023-08-17 · Open, Classified

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

Product labeling contains incorrect expiration date

Action taken

On June 28, 2023, Medtronic Neurosurgery issued a "Urgent: Medical Device Recall" Notification to affected consignees via FedEx and email. Medtronic asked consignees to take the following actions: 1. Immediately identify and quarantine unused affected products within your inventory. 2. Return the affected product per the return instructions listed in the Customer Confirmation Form. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. 4. Share this recall notification with all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 5. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: " Contact Medtronic Customer Quality at rs.mnsprodexperiencehelp@medtronic.com " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm " FDA telephone at 1-800-FDA-1088 (1-800-332-1088)

Root cause

Labeling Change Control

Status

Open, Classified

Product code

JXG

Quantity affected

44 units

Distribution

US Nationwide distribution in the states of NJ, FL, CA, IL.

Date initiated

2023-06-28

Date posted

2023-08-17

Location

Irvine, CA

Related 510(k) clearances