Z-1684-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 24, 2023
- Termination Date
- August 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 cases (165 cassettes)
Product Description
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Reason for Recall
Some of the ambIT kits were potentially distributed without an air in-line filter.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Code Information
Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)