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U.S. Department of Health and Human Services

Class 2 Device Recall Sodium Chloride (NaCl) Injection

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  Class 2 Device Recall Sodium Chloride (NaCl) Injection see related information
Date Initiated by Firm October 17, 2012
Date Posting Updated November 22, 2012
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-0430-2013
Recall Event ID 63479
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.
Code Information Lot number C866715, EXP OCT 13
Recalling Firm/
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Ryan LeMelle
Manufacturer 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.
FDA Determined
Cause 2
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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.