Recall Z-1174-2024 ยท NGT Saline, Vascular Access Flush
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 cases containing 400 syringes, Rx, Sterile.
| Date | Feb 22, 2024 (initiated Dec 28, 2023) |
| Status | Open, Classified |
| Reason | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued a letter dated 12/28/2023 via email. The letter explained the reason for recall, risk to health, and actions to be taken. The actions included the consignee examine their inventory and discontinue distribution and use immediately. All products should be segregated. A Shipment Summary and Acknowledgment Form was enclosed for completion and return to indicate the consignee has read and understands the recall instructions, identified and quarantined the affected product in inventory, and that the consignee has notified their customers who were shipped the product. I |
| Quantity | 3,080,000 syringes |
| Distribution | US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113555 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA, Jan 30, 2012 |