FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may … [Read more...]

FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected … [Read more...]

Recall Classification: Class I Date Recall Initiated: December 23, 2009 Product Names: * Exel Huber Needles * EXELint Huber Needles * Exel Huber Infusion Sets * EXELint Huber Infusion Sets * Exel "Securetouch+" Huber Safety Sets * EXELint Huber Safety Sets ALL LOT NUMBERS BEGINNING WITH 07, 08, OR 09 ARE AFFECTED BY THIS … [Read more...]

FDA Announces Class I Recall of Certain Infusion Set Needles Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion … [Read more...]

Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be … [Read more...]