MRP, LLC dba Aquabiliti: 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 c

Hazard

The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.

Details from the source

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. Quantity: 3,080,000 syringes 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.

UPC codes

10859809005013, 10859809005037

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.