Z-1686-2023 Class II Terminated
FDA device recall Z-1686-2023 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: 45 cases (225 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
- 45 cases (225 cassettes)
Product Description
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
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): 30195563 (17 Jan 2025); 30190578 (17 Jan 2025)