Baby and kids' product recalls

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

The puffer jackets have a drawstring located inside the lining of the bottom area of the garment. The drawstring can become entangled or caught on playground slides, handrails, school bus doors or other moving objects, posing an entanglement hazard to children.

The button on some buckles that release the harness can break and detach when pressed by the user while the child is in the stroller, making it difficult to release, and posing a choking hazard to young children.

Produced Without Benefit of Inspection

The products contain sodium hydroxide or potassium hydroxide which must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals.

The attachment that connects the swing hanger to the top tube can fail, posing an injury hazard.

The products contain sodium and potassium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.

The products contain sodium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violate the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.

The coin cell battery inside the slap watches can fall out, posing battery ingestion and choking hazards to young children.

The smoke alarm and the combination smoke/carbon monoxide (CO) alarm can fail to alert consumers to a fire.

Potential presence of a metallic mesh material in products.

The touchscreen on the treadmill can detach and fall, posing a risk of injury to consumers.

Adult users, children, pets and objects can be pulled underneath the rear of the treadmill, posing a risk of injury or death.

Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.

The size of the neck opening is too large for infants 0 to 6 months, which can allow an infant's head to slip into and be covered by the sleep bag, posing a risk of suffocation.

The products contain sodium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violate the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.

IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

Foreign object found in bottle.

The product is a dietary supplement containing iron, which must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a poisoning risk if the contents are swallowed by young children.

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.

Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

The recalled jackets have a drawstring in the hood and a drawsting in the waist area that can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a strangulation and/or an entrapment hazard to children.

Product Contamination