Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Recalled by Terumo Cardiovascular Systems Corporation Due to Over-Pressure Safety Valves not cleared with an indication...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.
Affected Products
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Quantity: 24,227.
Why Was This Recalled?
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report