Class 2 Device Recall Prismaflex Control Unit

• Date Initiated by Firm: January 28, 2021
• Create Date: March 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1277-2021
• Recall Event ID: 87299
• 510(K)Number: K072093
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
• Code Information: GTIN 07332414073718 (Product code 107493), serial numbers PA0105, PA0104, PA0106, PA0102, PA0107, PA0112, PA0111, PA0117, PA0113, PA0120, PA0127, PA0124, PA0130, PA0132, PA0131, PA0134, PA0128, PA0136, PA0141, PA0140, PA0143, PA0142, PA0148, PA0149, PA0147, PA0153, PA0152, PA0150, PA0163, PA0162, PA0160, PA0159, PA0158, PA0165, PA0164, PA0177, PA0176, PA0169, PA0167, PA0166, PA0180, PA0179, PA0184, PA0178, PA0188, PA0186, PA0195, PA0199, PA0211, PA0216, PA0214, PA0209, PA0205, PA0216, PA0204, PA0222, PA0217, PA0226, PA0231, PA0230, PA0229, PA0219, PA0229, PA0232, PA0243, PA0242, PA0238, PA0244, PA0241, PA0254, PA0252, PA0251, PA0240, PA0257, PA0255, PA0260, PA0259, PA0266, PA0262, PA0264, PA0269, PA0267, PA0273, PA0268, PA1007, PA1006, PA1003, PA1005, PA1002, PA0290, PA0287, PA0286, PA0284, PA0282, PA0281, PA0280, PA0274, PA1004, PA0285, PA0283, PA0279, PA0299, PA1016, PA1018, PA0300, PA0291, PA0363, PA0314, PA0362, PA0348, PA0367, PA0355, PA0346, PA0344, PA0340, 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• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: 800-422-9837
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Correction communication and reply form were sent to affected customers via U.S.P.S., first class mail on January 28, 2021.
• Quantity in Commerce: 4946 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = GAMBRO