Terumo Cardiovascular Systems Corporation recalls TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
- Recall date
- June 27, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0256-2018
- FDA classification
- Class II
- Brand / firm
- Terumo Cardiovascular Systems Corporation
- Sold / distributed
- Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Why it was recalled
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
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