FDA Recalls: St. Jude ICD and CRT-D, Cesar Classics Dog Food, Blue Bell Ice Cream, Blue Bunny Hoppin’ Holidoodle Ice Cream
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices
FDA and St. Jude Medical are alerting patients to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices.
St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
At this time, 349,852 affected devices remain actively implanted worldwide.
Read the MedWatch safety alert at:
Mars Petcare US Announces Voluntary Recall of CESAR® Classics Filet Mignon Flavor Wet Dog Food Because of Potential Presence of Plastic
Mars Petcare US of Franklin, Tennessee, announced a voluntary recall of a limited number of CESAR Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process.
Blue Bell Recalls All Products Made With Aspen Hills Cookie Dough Due To Potential Health Risk
Blue Bell Ice Cream is voluntarily recalling all products that were made with a cookie dough ingredient supplied by a third party supplier Aspen Hills, Inc., due to the potential for them to contain Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Blue Bunny Hoppin’ Hollidoodle Ice Cream Voluntary Recall
Wells Enterprises, Inc. is voluntarily recalling two lots of Blue Bunny Hoppin’ Holidoodle ice cream sold at retail outlets, because they contain snickerdoodle cookie dough pieces recalled by the supplier, Aspen Hills, due to potential contamination with Listeria monocytogenes.