ICU Medical product recalled over sterility concerns
- Recall date
- May 31, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
- Recall number
- D-0883-2018
- FDA classification
- Class II
- Brand / firm
- ICU Medical Inc
- Sold / distributed
- Nationwide and Canada
Why it was recalled
Lack of assurance of sterility: Bags have potential to leak.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
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