Z-0926-2017Class I

Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product...

Name: Z-0926-2017 Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product...
Creator: Nurse Assist, Inc
Published: 2016-10-04
License: https://open.fda.gov/license/

Nurse Assist, LLC / initiated 2016-10-04 / Terminated

FDA source

Nurse Assist, Inc began a recall of Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage... on 2016-10-04. FDA classified it as Class I and gives the reason as "Potential contamination with B. cepacia". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0926-2017
Classification: Class I
Status: Terminated
Initiated: 2016-10-04
Posted: 2017-01-03
Terminated: 2017-08-16
Recalling firm: Nurse Assist, LLC
Product: Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Potential contamination with B. cepacia.
FDA root cause: Unknown/Undetermined by firm
Action: Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email [email protected]. For questions regarding this recall call 817-231-1300.
Quantity in commerce: 386,175 syringes
Distribution: Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
Product codes and lots: Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0926-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-03

Product code NGT

K150143Class IINormal Saline FlushNurse Assist, Inc. / cleared 2015-08-31

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)