Z-1247-2021 Class II Terminated
FDA device recall Z-1247-2021 was initiated by Medtronic Vascular on January 15, 2021 and is designated Class II. Reason for recall: Sterility may be compromised due to an unsealed pouch The recall status is terminated (terminated June 15, 2023). Affected quantity: 10 Units.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- June 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 Units
Product Description
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Reason for Recall
Sterility may be compromised due to an unsealed pouch
Distribution Pattern
Nationwide
Code Information
Lot Code: 220772561, 220772562