Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Reported: March 31, 2021 Initiated: January 28, 2021 #Z-1279-2021
Product Description
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 1650 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).. Recalled by Baxter Healthcare Corporation. Units affected: 1650 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1279-2021.
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