AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, i

FDA device recall Z-1174-2024 · posted 2024-02-22 · Open, Classified

Recall details

Recalling firm

MRP, LLC dba Aquabiliti

Reason for recall

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

Action taken

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. It goes onto list the specific lot numbers and quantity of affected product sent to the consignee and asks for the quantity of product consumed and the quantity available for return. The letter was also issued via certified mail on 1/4/2024. The firm issued a corrected letter dated 1/8/2024 to correct the table listing lot numbers on Page 2 of the letter. Those lot numbers were asterisked for ease of identification by the consignee. The lot numbers listed on the Shipment Summary and Acknowledgment Form were correct in the original letter.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NGT

Quantity affected

3,080,000 syringes

Distribution

US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA.

Date initiated

2023-12-28

Date posted

2024-02-22

Location

Nashville, TN

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