Z-1709-2015Class II

0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage...

Name: Z-1709-2015 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage...
Creator: MRP, LLC dba AMUSA
Published: 2015-04-27
License: https://open.fda.gov/license/

Aquabiliti / initiated 2015-04-27 / Terminated / root cause: manufacturing process

FDA source

MRP, LLC dba AMUSA began a recall of 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe on 2015-04-27. FDA classified it as Class II and gives the reason as "Incorrect expiration date on label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1709-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Posted: 2015-06-04
Terminated: 2016-05-02
Recalling firm: Aquabiliti
Product: 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Incorrect expiration date on label
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete and return the enclosed Product Tracking and Verification Form. Please contact your AMUSA customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the corrections. Customers can also contact the Director, Quality Assurance at 513-325-1940 or email [email protected].
Quantity in commerce: 200,000 units
Distribution: US Distribution in states of:OH, PA, AL, IL, TN, and CT.
Product codes and lots: CODES: KH04103, KH04104, KH04105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1709-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1709-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code NGT

K133685Class II0.9% Sodium Chloride Flush SyringeAm USA / cleared 2014-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)