AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, i
Summary
The FDA issued a Class II for AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, RE by MRP, LLC dba Aquabiliti. Reason: The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months..
Details
Source
Device Recall
External ID
Z-1174-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: REF 2T0805 - Lot numbers KH04910, exp. 1/11/2024; KH04930, exp. 3/13/2024; KH04954, exp. 5/22/2024; KH04975, exp. 8/2/2024; 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.
Quantity Affected: 3,080,000 syringes
Reason for Recall
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Distribution
US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-28
Company
Nashville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MRP, LLC dba Aquabiliti) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MRP, LLC dba Aquabiliti have FDA actions?
This is the only FDA action we have on record for MRP, LLC dba Aquabiliti in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1174-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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