Reported Nov 28, 2012 · Terminated

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

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

    • 0.9% Sodium Chloride Injections
    • USP
    • 1000ml
  • VWR/Baxter Product UsageThe 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
Lot codes and dates
    • Lot number C866715
    • EXP OCT 13
Amount recalled
199 cases/14-1000mL bags

This recall covers 32 products

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2013 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.