Devices

Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves

Model / Serial
Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to the states of MO and FL.
Product Description
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves

Manufacturer

Terumo Cardiovascular Systems Corp

Manufacturer Address
Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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