Devices

Device Recall AMICUS Exchange Kit

Model / Serial
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
Product Classification
Gastroenterology-Urology Devices
Device Class
Unclassified
Implanted device?
No
Distribution
USA Nationwide Distribution
Product Description
AMICUS Exchange Kit; || Product Usage: || This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Manufacturer
Fenwal Inc
1 Event
- Recall of Device Recall AMICUS Exchange Kit

Manufacturer

Fenwal Inc

Manufacturer Address
Fenwal Inc, 3 Corporate Dr Ste 300, Lake Zurich IL 60047-8930
Manufacturer Parent Company (2017)
Fresenius SE & Co. KGaA
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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