Devices

Device Recall System 1000, Arena, 1550, BM11, BM25, Meridian

Model / Serial
System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers BM25: all serial numbers Meridian: serial numbers 200101-203156
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Morocco, Malaysia, Netherlands, Oman, Panama, Peru, Philippines, Poland, Palestine, Romania, Russia, Saudia Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
Product Description
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Manufacturer
Baxter Healthcare Renal Div
1 Event
- Recall of Device Recall System 1000, Arena, 1550, BM11, BM25, Meridian

Manufacturer

Baxter Healthcare Renal Div

Manufacturer Address
Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
Source
USFDA

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