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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

MRP, LLC dba Aquabiliti: Saline Flush Syringes Recalled for Potential Potency Loss

Agency Publication Date: February 22, 2024
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Summary

MRP, LLC dba Aquabiliti has recalled approximately 3,080,000 AQUASTAT 0.9% Sodium Chloride Injection syringes because the saline solution may not maintain the correct salt concentration after 12 months. This recall affects various lots of the 5mL and 3mL syringes used to flush medical lines. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates ranging from early 2024 to late 2025. Because this is a medical device issue, you should contact your healthcare provider or the manufacturer for instructions on returning the product.

Risk

The syringes may fail to meet the required USP standards for sodium chloride content after being stored for a year, which could result in patients receiving a solution with incorrect saline levels. While no injuries have been reported, using sub-potent saline flushes in a clinical setting could impact the effectiveness of medical treatments or line maintenance.

What You Should Do

  1. Check your inventory for AQUASTAT 0.9% Sodium Chloride Injection syringes (5mL in 12mL, REF 2T0805) with lot numbers KH04910, KH04930, KH04954, KH04975, KH04990, KH05020, KH05022, KH05043, KH05066, KH05068, KH05070, KH05073, KH05134, KH05135, or KH05152.
  2. Check your inventory for AQUASTAT 0.9% Sodium Chloride Injection syringes (3mL in 12mL, REF 2T0807) with lot numbers KH04909, KH04944, KH04986, KH04988, KH05024, KH05026, or KH05071.
  3. Identify the affected products by looking for UDI-DI 10859809005013 (5mL) or 10859809005037 (3mL) on the intermediate cartons or shipping cases.
  4. Immediately stop using the affected lot numbers and quarantine the product to prevent further use.
  5. Contact your healthcare provider or the manufacturer, MRP, LLC dba Aquabiliti, at their Nashville location (5209 Linbar Dr Ste 640, Nashville, TN 37211) for specific instructions on product return and potential replacement or refund.
  6. Contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe (5mL in 12mL)
Model / REF:
REF 2T0805
UDI-DI 10859809005013
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)
KH05152 (exp. 10/10/2025)
Product: AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe (3mL in 12mL)
Model / REF:
REF 2T0807
UDI-DI 10859809005037
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)
KH05071 (exp. 12/19/2024)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93848
Status: Active
Manufacturer: MRP, LLC dba Aquabiliti
Sold By: hospital supply distributors; medical providers
Manufactured In: United States
Units Affected: 3,080,000 syringes
Distributed To: Colorado, Florida, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.