The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products. The complaint also names Rel's Vice President, Peder Scott … [Read more...]
Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: … [Read more...]
Neuron 6F 070 Delivery Catheter – Penumbra
Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage … [Read more...]
Niles, Ill. Firm Issues Allergy Alert on Classic Candy
Affy Tapple, LLC, a Niles, Ill. firm, is voluntarily recalling its "Limited Edition – Classic Candy Flavors" two-pack caramel apples because the label did not include the allergen statement "manufactured on shared equipment with peanuts and tree nuts". Consumers who have an allergy to peanuts may run the risk of a serious allergic reaction if they … [Read more...]
Philips Recalls Select Heartstart Fr2+ Automated External Defibrillators
Philips is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, … [Read more...]
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