AQUABILITI AQUASTAT 0 — Class II medical device recall Z-1174-2024
Ongoing recall by MRP, LLC dba Aquabiliti, reported 2024-02-28, distributed nationwide. The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
| Recall number | Z-1174-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MRP, LLC dba Aquabiliti, Nashville, TN, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,080,000 syringes |
| Reason classes | device malfunction |
| Lot numbers | KH04909, KH04910, KH04930, KH04944, KH04954, KH04975, KH04986, KH04988, KH04990, KH05020, KH05022, KH05024, KH05026, KH05043, KH05066, KH05068, KH05070, KH05071, KH05073, KH05134, KH05135, KH05152 |
| Model numbers | 2T0805, 2T0807 |
| Expiration dates | 2024-01-10, 2024-01-11, 2024-03-13, 2024-04-24, 2024-05-22, 2024-08-02, 2024-08-30, 2024-09-05, 2024-09-06, 2024-10-23, 2024-10-24, 2024-10-25, 2024-10-26, 2024-11-13, 2024-12-13, 2024-12-14, 2024-12-18, 2024-12-19, 2024-12-20, 2025-06-25, 2025-06-27, 2025-10-10 |
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 for recall
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1174-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.