0 — Class II medical device recall Z-0430-2013
Terminated recall by Biomerieux Inc, reported 2012-11-28, distributed nationwide. The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for
| Recall number | Z-0430-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2012-10-17 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | C866715 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0430-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.