FDA-Device2017-12-27Class II
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Terumo Cardiovascular Systems Corporation
Hazard
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Sold states
Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Affected count
297,222 units
Manufactured in
125 Blue Ball Rd, Elkton, MD, United States
Products
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0256-2018Don't want to check this manually?
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