ICU Medical product recalled over manufacturing violations
- Recall date
- February 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC…
- Recall number
- D-0509-2019
- FDA classification
- Class II
- Brand / firm
- ICU Medical Inc
- Sold / distributed
- Nationwide within the United States
Why it was recalled
CGMP Deviations
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 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
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