North Dakota recalls

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

The devices may have a misaligned thickness control bar.

The devices may have a misaligned thickness control bar.

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Subpotent product:out of specification assay results observed during long term stability testing.

Subpotent product:out of specification assay results observed during long term stability testing.

Subpotent product:out of specification assay results observed during long term stability testing.

Presence of Foreign Tablets/Capsules

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Defective container: cracked/broken cartridges

Product Contamination

The children's toy violates the mandatory standard for toys because the toy cell phone contains button cell batteries and the toy tablet contains a lithium coin battery that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The compression strap that surrounds the outside of the pool legs may create a foothold, allowing a child access to the pool, posing a drowning risk.

The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The resulting fire can cause serious injury or death from smoke inhalation and burns.

The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

The beard serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.