Devices

Device Recall Modified MP4Cardioplegia Delivery System with Conducer

Model / Serial
Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Product Description
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass || Item Numbers: 5852, 16010 || Product Usage: || This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of Device Recall Modified MP4Cardioplegia Delivery System with Conducer

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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