Devices

Device Recall CAPIOX Flexible Venous Reservoir

Model / Serial
CAPIOX Flexible Venous Reservoir, Lot NE13, (used as single units) or as a component in sterilized custom cardiovascular procedure kits with kit lot numbers NC21 R, ND21 R, NF02, and NF02.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
(USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.
Product Description
CAPIOX¿ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** || Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
Manufacturer
Terumo Cardiovascular Corporation
1 Event
- Recall of Device Recall CAPIOX Flexible Venous Reservoir

Manufacturer

Terumo Cardiovascular Corporation

Manufacturer Address
Terumo Cardiovascular Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
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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