CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
0.9% Sodium Chloride Injections, USP, VWR/Baxter recalled by Biomerieux
Biomerieux is recalling 0.9% Sodium Chloride Injections, USP, VWR/Baxter, distributed nationwide in the US. The recall was initiated on 17 Oct 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0430-2013
- FDA event ID
- 63479
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2012
- FDA classified
- 21 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2012 | Recall initiated by company | |
| 21 Nov 2012 | Classified by FDA | +35 days |
| 28 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it 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.
Which lots are affected?
Lot number C866715, EXP OCT 13
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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