Recall Z-0430-2013— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2012-10-17, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-17
- Terminated
- 2013-12-05
- Firm location
- Hazelwood, MO, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.