Baby and kids' product recalls

Lack of Assurance of Sterility: Potential leakage of bags.

Incorrect Product Formulation: wrong sunscreen product in the package.

The patches on the shorts can detach, posing a choking hazard to young children.

Product Contamination

Del Monte has recalled the products because they may be linked to this recent cluster of illnesses and have the potential to be contaminated with Cyclospora

Del Monte has recalled the products because they may be linked to this recent cluster of illnesses and have the potential to be contaminated with Cyclospora

The children's pajamas fail to meet the flammability standard for children's sleepwear, posing a risk of burn injuries to children.

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Misbranding

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

The bottles are mislabeled with an incorrect part number.

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

Produced Without Benefit of Inspection

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

The recalled strollers violate the federal Stroller and Carriage standard. An infant can pass through the opening between the stroller armrest and the seat bottom and his/her head and neck can become entrapped by the armrest, posing entrapment and strangulation hazards.

A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.

The product test positive for peanuts and almond allergen which is not declared on the product label.

The wheels and axles can detach from the wooden toy car, posing a choking hazard to young children.

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.

Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.