Devices

Device Recall Conducer Cardioplegia Set SITH MP4

Model / Serial
Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 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- || Catalog Number:165720 and Catalog Number: 6375 || Product Usage: || 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: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure 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 Conducer Cardioplegia Set SITH MP4

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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