FDA Device recall Z-1174-2024
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805 by Mrp, citing the saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1174-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-28 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mrp |
| Distribution | US |
Product
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
Reason
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Identifiers
| code_info | REF 2T0805 - Lot numbers KH04910, exp. 1/11/2024; KH04930, exp. 3/13/2024; KH04954, exp. 5/22/2024; KH04975, exp. 8/2/2…REF 2T0805 - Lot numbers KH04910, exp. 1/11/2024; KH04930, exp. 3/13/2024; KH04954, exp. 5/22/2024; KH04975, exp. 8/2/2024; KH04990, exp. 9/6/2024; KH05020, exp. 10/23/2024; KH05022, exp. 10/24/2024; KH05043, exp. 11/13/2024; KH05066, exp. 12/13/2024; KH05068, exp. 12/14/2024; KH05070, exp. 12/18/2024; KH05073, exp. 12/20/2024; KH05134, exp. 6/25/2025; KH05135, exp. 6/27/2025; and KH05152, exp. 10/10/2025; UDI-DI 10859809005013. REF 2T0807 - Lot numbers KH04909, exp. 1/10/2024; KH04944, exp. 4/24/2024; KH04986, exp. 8/30/2024; KH04988, exp. 9/5/2024; KH05024, exp. 10/25/2024; KH05026, exp. 10/26/2024; and KH05071, exp. 12/19/2024; UDI-DI 10859809005037. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1174-2024%22
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