Z-0430-2013 Class II Terminated
FDA device recall Z-0430-2013 was initiated by Biomerieux Inc on Oct 17, 2012 and is designated Class II. 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. The recall status is terminated (terminated Dec 5, 2013). Affected quantity: 199 cases/14-1000mL bags.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Oct 17, 2012
- Termination Date
- Dec 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 199 cases/14-1000mL bags
Product Description
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.
Distribution Pattern
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.
Code Information
Lot number C866715, EXP OCT 13
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0430-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026