Devices

Device Recall 8" Extension Set with SmartSite(TM) HEPLock and Rotating Luer Lock. SmartSite(TM)

Model / Serial
Product number MPI-17635.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
Product Description
8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. || An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall 8" Extension Set with SmartSite(TM) HEPLock and Rotating Luer Lock. SmartSite(TM)

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Road, Reading PA 19605
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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