Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
The bottles are not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if the contents are swallowed by young children.
The cooler latch can automatically lock when the lid is closed, allowing a person to become locked inside the air tight container posing entrapment and suffocation hazards.
Infant fatalities have been reported while using other inclined sleep products, after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances.
The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.