Z-1828-2021 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 21, 2021
- Termination Date
- February 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Reason for Recall
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Distribution Pattern
U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
Code Information
Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM