Washington recalls

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

cGMP deviations.

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

The minifridges' internal electrical components can short circuit and ignite the surrounding plastic housing, posing fire and burn hazards.

The beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The 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.

The recalled self-feeding pillows hold the bottle at an unsafe angle while keeping it fixed in place so the infant cannot pull away. This can lead to aspiration of milk or formula, posing a risk of suffocation.

The power strips have an ungrounded metal enclosure that poses an electrocution hazard if energized, resulting in serious injury or death.

The recalled children's pajamas violate the mandatory standards for flammability of children's sleepwear, posing a risk of serious injury and deadly burn hazards to children.

The recalled chairs can crack and collapse, posing injury and fall hazards.

The aftermarket mattresses violate the mandatory standard for crib mattresses, as the mattresses may not adequately fit certain play yards or non-full-sized cribs, which could create gaps posing a deadly entrapment hazard. Babies can face a risk of suffocation in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant from breathing.

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.

The lithium-ion batteries installed in the lanterns can overheat, posing a burn hazard to consumers.

The serum bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The 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.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.

Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.

Device packaged in incorrect outer box carton.

Customer complaints of Pressio monitor rebooting.

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.