0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prep

FDA device recall Z-0430-2013 · posted 2012-11-22 · Terminated

Recall details

Recalling firm

Biomerieux Inc

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.

Action taken

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

Status

Terminated

Quantity affected

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. Distri

Date initiated

2012-10-17

Date posted

2012-11-22

Date terminated

2013-12-05

Location

Hazelwood, MO