Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling 4,946 units of the Prismaflex Control Unit used for continuous renal replacement therapy. The tubing in the Automatic Repositioning System (ARPS) Pump Assembly may perform variably, which could trigger alarm situations during or after the system's self-test. The affected units have product code 107493 and include numerous specific serial numbers ranging from PA0102 through PA0413.
The recalled devices were distributed worldwide, including throughout the United States and Puerto Rico, as well as in numerous countries across Europe, the Middle East, Africa, Asia, and Canada. The source document does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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 Quantity: 4946 units Lot/code info: 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, PA0295, PA1014, PA1011, PA0369, PA0351, PA0345, PA0319, PA0311, PA0376, PA0375, PA0373, PA0371, PA0304, PA0301, PA0343, PA0322, PA0309, PA0361, PA0324, PA0323, PA1017, PA0381, PA0378, PA0377, PA0339, PA0382, PA0380, PA0350, PA0326, PA0321, PA0315, PA0379, PA0342, PA0318, PA0384, PA0327, PA0317, PA0308, PA0357, PA1028, PA1019, PA0389, PA0388, PA0387, PA0332, PA0398, PA0394, PA0392, PA0391, PA0390, PA0397, PA0395, PA0405, PA0402, PA0401, PA0399, PA0410, PA0409, PA0407, PA0403, PA1035, PA1033, PA1035, PA1033, PA0413, PA
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.