Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0430-2013 |
| Classification | Class II |
| Code Info | Lot number C866715, EXP OCT 13 |
| Product Distributed Qty | 199 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. |
Event Detail
| Event Id | 63479 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Biomerieux Inc |
| City | Hazelwood |
| State | MO | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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