—#114061

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.

Affected lot / code info: Lot number C866715, EXP OCT 13

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

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.

Timeline

Recall initiated: 2012-10-17
Posted by FDA: 2012-11-22
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114061. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.