Z-2476-2015Class II

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution

Name: Z-2476-2015 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution
Creator: MRP, LLC dba AMUSA
Published: 2015-07-02
License: https://open.fda.gov/license/

Aquabiliti / initiated 2015-07-02 / Terminated / root cause: packaging

FDA source

MRP, LLC dba AMUSA began a recall of 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution on 2015-07-02. FDA classified it as Class II and gives the reason as "Procedures for the acceptance and control of in-process product have not been adequately established". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2476-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-02
Posted: 2015-08-27
Terminated: 2017-04-03
Recalling firm: Aquabiliti
Product: 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Procedures for the acceptance and control of in-process product have not been adequately established.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.
Quantity in commerce: 551 cases
Distribution: Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
Product codes and lots: KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2476-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2476-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27

Product code NGT

K120836Class II0.9% Sodium Chloride Flish SyringeAm USA / cleared 2012-07-12

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)