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Terminated

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.

FDA Recall Z-0430-2013 · Posted 2012-11-22

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Date Initiated2012-10-17
Date Terminated2013-12-05
Product Quantity199 cases/14-1000mL bags

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.

Firm 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.

Root Cause

Employee error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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