| | Class 2 Recall
Sodium Chloride (NaCl) Injection |  |
| Date Posted |
November 22, 2012 |
| Recall Number |
Z-0430-2013 |
| 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/
Manufacturer |
Biomerieux Inc
595 Anglum Rd
Hazelwood, Missouri 63042-2320 |
| For Additional Information Contact |
Ryan LeMelle
314-731-8526
|
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 |
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. |
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