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Recall Observatory FDA recall evidence

Device 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.

Z-0430-2013

October 17, 2012

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 63479
Status
Terminated
Classification
Class II
Quantity
199 cases/14-1000mL bags
Official record key
device-enforcement:Z-0430-2013

Official wording

Reason: 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.

Code information: Lot number C866715, EXP OCT 13

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.