FDA-Device2021-03-31Class II
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
Hazard
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
Sold states
Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Malta, Mauritius, Montenegro, Morocco, Netherlands, Nigeria, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Syria, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Yemen, Australia, New Zealand, China, Japan, Korea, Taiwan, Hong Kong, India, Thailand, Singapore, Malaysia, Vietnam, Grand Cayman, Dominican Republic, St. Kitts, Venezuela, Argentina, Chile, Barbados, Bermuda, Costa Rica, Cuba, Haiti, Guatemala, Colombia, Trinidad & Tobago, Mexico, and Brazil.
Affected count
35175 kits
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2021Don't want to check this manually?
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