Device product
SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Z-1687-2023
Product summary
- Event
- Event 92279
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 cases (200 cassettes)
- Official record key
device-enforcement:Z-1687-2023
Official wording
Reason: Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information: Lot Number (Expiration Date): 30191805 (17 Jan 2025)
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.