Aquabiliti saline flush syringes recalled for potential sodium chloride content deficiency
MRP, LLC is recalling AQUABILITI AQUASTAT saline flush syringes because they may fail to meet USP standards for sodium chloride content after 12 months.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is a potential quality defect involving failure to meet USP specifications for sodium chloride content, affecting a risk-of-harm product where injury has not yet been reported.
Plain-English summary
MRP, LLC, doing business as Aquabiliti, is recalling AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringes in multiple lot numbers. The product consists of 5mL and 3mL fill volumes in 12mL syringe barrels, with reference numbers 2T0805 and 2T0807. Approximately 3,080,000 syringes have been recalled.
The syringes may fail to meet USP specifications for sodium chloride content after 12 months of storage. This potential quality defect could affect the product's ability to perform as intended.
The recalled syringes were distributed nationwide in Colorado, Florida, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Affected lot numbers with specific expiration dates are available in the FDA's recall notice.
The recalled product
- 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.
- Manufacturer
- MRP, LLC dba Aquabiliti
- Hazard
- improper-concentration
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27