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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 INFORMED and/or REMARCS newsletters.
Below are links to the most recent recalls, reviews, and advisories affecting the dialysis community:
SteriChek "Sensitive" Total Chloramines and Residual Chlorine Reagent Strips Recall (7/2008)
BD 60 ml Luer-Lok Syringes Recall (7/2008)
Icodextrin (marketed as Extraneal) and Point-of-Care Glucose Monitoring Devices (6/2008)
Cardinal Health Mouthwash Recall (6/2008)
Digitek Recall (5/2008)
Dietary Supplements May Affect Blood Pressure (4/2008)
Regranex Gel May Increase Risk of Cancer (4/2008)
Singulair Possibly Associated with Behavior Changes, Suicide (4/2008)
Risk of Allergic Reaction to Denture Cleansers (3/2008)
Tysabri Prescribing Information REVISED (3/2008)
Pre-filled Heparin Flush Lock Solution Recall EXPANDED (2/2008)
Recall of Baxter Heparin following reports of allergic-type reactions among dialysis and other patients in multiple states (1/2008)
Pre-Filled Heparin Lock Flush Solution - Nationwide Recall (12/2007)
Bayer Diabetes Care Test Strips - Voluntary Recall (12/2007)
Welch Allyn AED 10 Automatic External Defibrillators Recall (12/2007)
Warning Regarding Avandia (Rosiglitazone Maleate) Tablets (12/2007)
Contrast Agents Linked to Serious Reactions; Labeling Changes (11/2007)
Acute Pancreatitis Linked to Byetta (11/2007)
For additional recall, review, or advisory information not listed here, visit the FDA's MedWatch Safety Information and Adverse Reporting Program web site.
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