International Medical Devices Database

Manufacturer Address
Fresenius Hemocare, Inc., 6675 185th Ave. NE, Suite 100, Redmond WA 98052
Source
USFDA
2 Events
- Recall of Prosorba Protein A Immunoadsorption Column
- Recall of Device Recall Fresenius

2 devices in the database

Prosorba Protein A Immunoadsorption Column

Model / Serial
Lot #PNC001A
Product Classification
Gastroenterology-Urology Devices
Device Class
3
Implanted device?
No
Distribution
The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.
Product Description
Prosorba Protein A Immunoadsorption Column

Device Recall Fresenius

Model / Serial
ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.
Product Description
ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. || The component that is the subject of the recall is the AT1 Autotransfusion Set.

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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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Fresenius Hemocare, Inc.

2 devices in the database

Prosorba Protein A Immunoadsorption Column

Device Recall Fresenius