Z-1685-2023 Class II Terminated
FDA device recall Z-1685-2023 was initiated by Avanos Medical, Inc. on April 24, 2023 and is designated Class II. Reason for recall: Some of the ambIT kits were potentially distributed without an air in-line filter. The recall status is terminated (terminated August 2, 2024). Affected quantity: 57 cases (285 cassettes).
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
- 57 cases (285 cassettes)
Product Description
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
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): 30177647 (17 Dec 2023); 30174128 (14 Oct 2023)