The U.S. Food and Drug Administration (FDA), in addition to private companies, often issue product recalls, reviews, and/or advisories that affect the dialysis community. Some recalls may relate to equipment malfunctions or hazards, or even medication administration or dosage. MARC relays all recalls or warning as we are apprised. Methods of notification include, but are not limited to, posting links to the appropriate notice on the MARC website; emailing, faxing, or mailing notices to facility personnel; and publication in the Network's e-lerts and/or REMARCS newsletters.
Below are links to the most recent recalls, reviews, and advisories affecting the dialysis community:
Due to a defect, the systems may fail unexpectedly. *A Class I Recall is defined as a situation where there is reasonable probability that the use of or exposure to a product will cause serious adverse effects or even death.
Class I Recall: Thoratec Corporation Recalls HeartMate II Left Ventricular Assist System (LVAS) Due to Kinking or Deforming of Outflow Graft *A Class I Recall is defined as a situation where there is reasonable probability that the use of or exposure to a product will cause serious adverse effects or even death. American Regent Recalls Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 ml Vial Lot #s 1662, 1679, and 1683 Due to Cracked Vials
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