Z-2394-2012Class III

0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only...

Name: Z-2394-2012 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only...
Creator: Amsino Medical USA
Published: 2012-08-15
License: https://open.fda.gov/license/

Aquabiliti / initiated 2012-08-15 / Terminated / root cause: manufacturing process

FDA source

Amsino Medical USA began a recall of 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN... on 2012-08-15. FDA classified it as Class III and gives the reason as "One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL". 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-2394-2012
Classification: Class III
Status: Terminated
Initiated: 2012-08-15
Posted: 2012-09-15
Terminated: 2013-08-13
Recalling firm: Aquabiliti
Product: 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Amusa, notified their sole consignee of the mislabeled product via e-mail and telephone on August 15, 2012. An "URGENT-CLASS II MEDICAL DEVICE RECALL" letter dated August 22, 2012 was sent to the customer. The letter identified the product, problem, and actions to be taken by the customer. A Response Form was included for the customer to complete and return. Contact the firm at 615-521-2723 for questions regarding this recall.
Quantity in commerce: unknown
Distribution: Distributed to one customer in Illinois.
Product codes and lots: KH03752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2394-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2393-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-15
Z-2394-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-15

Product code NGT

K111034Class IIAm USA 0.9% Sodium Chloride Flush SyringeAm USA / cleared 2011-07-14

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)