Heart Sync Inc. announces that it has notified customers of a Voluntary Urgent Device Correction for certain Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units.
Category Archives: Food & Drug Recalls
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products
The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products
The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
Whole Foods Market West Hartford, Bishops Corner and Glastonbury Recall Tarte Aux Pommes Due to Undeclared Almonds
Three Connecticut Whole Foods Market locations are recalling “Tarte Aux Pommes” produced and sold in West Hartford Center, Bishops Corner and Glastonbury, Connecticut due to an undeclared almonds. The 6 inch tarte was mislabeled as a “Tarte Aux Pomme 10in” and has a “best by” date between November 20 and December 1, 2014.
The six inch tarte contained almonds as an ingredient, which was not declared on the label.
Whole Foods Market’s Southwest Region recalls Vegan Pumpkin Pie due to Undeclared Walnuts
Whole Foods Market is recalling “Vegan pumpkin pie” produced and sold in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared walnuts.
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FDA allows marketing of non-invasive device to help evaluate heart blood flow
The U.S. Food and Drug Administration today allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.
Select Containers of Private Selection Denali Extreme Moose Tracks Ice Cream Recalled for Undeclared Allergen
The Kroger Co. (NYSE: KR) said today it is recalling select containers of Private Selection Denali Extreme Moose Tracks Ice Cream sold in 13 states because it may contain peanuts not listed on the label. Item Description:
Private Selection Denali Extreme Moose Tracks Ice Cream sold in 48-ounce containers with a “sell by” date of April 16, 2015 under the following UPC Code: 11110-00456.
CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes
CONMED Corporation announces that it has notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units.