Devices

Device Recall Baxter SPS 550 Hemodialysis Machine

Model / Serial
catalog numbers 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797;all serial numbers
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.
Product Description
Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015
Manufacturer
Baxter Healthcare Corp.
1 Event
- Recall of Device Recall Baxter SPS 550 Hemodialysis Machine

Manufacturer

Baxter Healthcare Corp.

Manufacturer Address
Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
Source
USFDA

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