Device product
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Z-1684-2023
Product summary
- Event
- Event 92279
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 cases (165 cassettes)
- Official record key
device-enforcement:Z-1684-2023
Official wording
Reason: Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information: Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Derived failure modes
-
Unknown
Some of the ambIT kits were potentially distributed without an air in-line filter.