FDA Device recall Z-1684-2023
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- FDA Device
- Class II
- terminated
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 by Avanos Medical, citing some of the ambIT kits were potentially distributed without an air in-line filter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1684-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-04-24 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avanos Medical |
| Distribution | US |
Product
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Reason
Some of the ambIT kits were potentially distributed without an air in-line filter.
Identifiers
| code_info | Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1684-2023%22
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