Xanodyne Pharmaceuticals, Inc. is cooperating with the FDA in recalling Darvocet and Darvon, their versions of the pain killer propoxyphene. Darvocet could cause serious and potentially fatal heart rhythm abnormalities, says the FDA.
12 REPORTS OF INFANTS BETWEEN THE AGES OF 1 MONTH AND 4 FOUR MONTHS WHO DIED WHEN THEY SUFFOCATED IN SLEEP POSITIONERS OR BECAME TRAPPED AND SUFFOCATED BETWEEN A SLEEP POSITIONER AND THE SIDE OF A CRIB OR BASSINET.
Integra LifeSciences Corporation, Plainsboro, New Jersey, has initiated a worldwide recall of the NeuroBalloon Catheter.
THE BOY WAS FOUND HANGING WITH HIS NECK ENTRAPPED BETWEEN THE PLAYARD FRAME AND THE METAL BASE ROD OF THE TENT THAT HAD BEEN PARTIALLY TIED BY PIECES OF NYLON ROPE AND PARTIALLY ATTACHED BY CLIPS. THE TENT WAS TIED TO THE PLAYARD BECAUSE THE CHILD WAS ABLE TO POP OFF THE CLIPS.
THE ORAL INFLATOR BUTTON IS NOT PROPERLY BONDED TO THE ORAL STEM AND CAN FALL OFF DURING USE, POSING A LEAK OF THE BUOYANCY COMPENSATOR CONTENTS. THIS POSES A DROWNING HAZARD.
CONSUMERS SHOULD IMMEDIATELY STOP USING THE RECALLED SLINGS AND CONTACT SPROUT STUFF TO RETURN THE SLING FOR A FULL REFUND.
CPSC HAS RECEIVED TWO REPORTS OF INJURIES THAT OCCURRED WHEN THE STORAGE TRUNKS’ LIDS SUDDENLY CLOSED ON CHILDREN, INCLUDING ONE REPORT OF AN 18-MONTH-OLD GIRL WHO REPORTEDLY SUFFERED BRAIN DAMAGE WHEN THE TRUNK’S LID CAME DOWN ON THE BACK OF HER NECK AND PINNED HER THROAT AGAINST THE RIM OF THE TRUNK.
AS PART OF ITS COMMITMENT TO ENSURE SAFE SLEEP FOR YOUNG CHILDREN, THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) IS ONCE AGAIN WARNING PARENTS AND CAREGIVERS ABOUT DEADLY HAZARDS WITH DROP-SIDE CRIBS.
STRANGULATIONS IN ROMAN SHADES OCCUR WHEN A CHILD PLACES HIS/HER NECK BETWEEN THE EXPOSED INNER CORD AND THE FABRIC ON THE BACK SIDE OF THE BLIND OR WHEN A CHILD PULLS THE CORD OUT AND WRAPS IT AROUND HIS/HER NECK.
This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma.
The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize. FDA has been apprised of this action.