Kentucky recalls

The recalled pounding toys violate the mandatory standard for toys because they contain high-powered magnets, which can detach, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, blood poisoning, and death.

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 tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

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 tip-over and entrapment hazards that can result in a risk of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, and have leg openings that allow the child to slip down until the child's torso can become entrapped, posing a risk of serious injury or death due to drowning and entrapment.

The pajama pants and shorts violate the mandatory standards for flammability of children's sleepwear, posing a risk of burn injuries to children.

The recalled padded crib bumpers violate the federal ban on crib bumpers because they can obstruct an infant's breathing, posing a risk of serious injury or death, due to suffocation. This creates an unsafe sleeping environment for infants. Padded crib bumpers are banned by the federal Safe Sleep for Babies Act.

The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, becoming entrapped, posing a risk of serious injury or death.

Pieces from the recalled leaf vacuums can come loose inside the unit, or debris can pierce the chute, resulting in material ejecting and posing a laceration hazard to users and bystanders.

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.

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

Butyrate tube cracks during actuation, rendering product unusable.

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)

Foreign material.

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

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.

Presence of Particulate Matter: Hair was found in a prefilled syringe

Presence of Particulate Matter: Hair was found in a prefilled syringe

Lack of Assurance of Sterlity

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured