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...]
Consumers Warned Not to Eat Certain Imported Dried Plums
The Texas Department of State Health Services is warning consumers not to eat certain imported dried plums and products containing imported dried plums because they have elevated levels of lead. Most of the products typically are sold as salted or candied treats in Asian and Hispanic markets but also are available in other retail outlets. … [Read more...]
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in … [Read more...]
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