Devices

Device Recall Integrated Cardioplegia Delivery Sets

Model / Serial
Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.
Product Classification
Cardiovascular Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Product Description
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 || Item Number: 16110 || Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of Device Recall Integrated Cardioplegia Delivery Sets

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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