Z-0430-2013Class II

0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter

Name: Z-0430-2013 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter
Creator: Biomerieux Inc
Published: 2012-10-17
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2012-10-17 / Terminated / root cause: manufacturing process

FDA source

Biomerieux Inc began a recall of 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the... on 2012-10-17. FDA classified it as Class II and gives the reason as "The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system". 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-0430-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-17
Posted: 2012-11-22
Terminated: 2013-12-05
Recalling firm: bioMerieux, Inc.
Product: 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.
Reason for recall: The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biomerieux sent an Urgent Product Removal Notice letter dated October 16, 2012 to all affected customers via certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected product and immediately discard any remaining inventory. The letter included instructions on receiving product replacement or credit. For questions or concerns contact your local BioMerieux representative.
Quantity in commerce: 199 cases/14-1000mL bags
Distribution: Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI. Distribution was also made to Canada, military facilities and other foriegn countries.
Product codes and lots: Lot number C866715, EXP OCT 13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0430-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0430-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)