Z-1808-2015Class II

T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use...

Name: Z-1808-2015 T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use...
Creator: MRP, LLC dba AMUSA
Published: 2015-02-09
License: https://open.fda.gov/license/

Aquabiliti / initiated 2015-02-09 / Terminated / root cause: manufacturing process

FDA source

MRP, LLC dba AMUSA began a recall of T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe on 2015-02-09. FDA classified it as Class II and gives the reason as "Incorrect labeling of the expiration date". 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-1808-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Posted: 2015-06-15
Terminated: 2015-06-22
Recalling firm: Aquabiliti
Product: T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Incorrect labeling of the expiration date
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: [email protected].
Quantity in commerce: 1,080 units (3 cases)
Distribution: US distribution to CA only.
Product codes and lots: KH04090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1808-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1808-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15

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)