Baby and kids' product recalls

Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.

The youth ATVs fail to meet performance requirements of the federal ATV standard for maximum unrestricted speed and parking brakes, posing a crash hazard.

The stitching on the restraint straps can loosen which allows the straps to separate from the seat, posing a fall hazard to children.

Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.

The firm was notified by two customers of two lot/batch numbers testing positive for Listeria monocytogenes which is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal

The firm is recalling Raw Walnuts because the products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In r

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Product Contamination

If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.

The hat can detach from the policeman's head and pose a choking hazard to young children.

The vintage gray paint on the cribs, furniture, and accessories exceeds federal lead limits. If ingested, lead can cause adverse health effects.

Misbranding, Unreported Allergens

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.

If the seats are built with this seat bottom foam core, the seats may not resist catching fire in the presence of an ignition source, increasing the risk that a fire may start or spread.

The crib mattresses could create a gap between the mattress and crib ends larger than allowed by federal regulations, posing an entrapment hazard to infants.

Import Violation

The end caps of the kaleidoscope can be removed and expose small parts that can come loose and pose a choking hazard to small children and internal components that pose a risk of laceration.

One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

The children's pajama sets fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injury to children.

The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.

Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.

Snaps on the coveralls can detach, posing a choking hazard to young children.

Wire-edged ribbon used in the blanket's ribbon tags can become exposed, posing a laceration hazard to children.

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.