Maine recalls

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, 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 folding mechanism on the blade can fail to remain properly secured in the closed position, posing a laceration hazard.

The ovens in the ranges can experience a delayed ignition of the oven's bake burner, posing a risk of burn hazards to users.

The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a risk of serious injury or death due to a fall hazard.

The recalled LED tumblers can break, making the button cell batteries accessible to children and posing choking and ingestion hazards. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The bike's fork steerer tube can develop a small fatigue crack that can lead to a progressive failure of the fork, posing a fall hazard.

The recalled chairs' base can bend, posing a fall hazard.

The attached hose can get excessively hot and the nozzle/gun can expel hot water during use and after the trigger is engaged, posing a serious burn hazard to consumers.

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

Product not cleared by the FDA.

Product not cleared by the FDA.

Product not cleared by the FDA.

Reports of devices sparking/popping and potentially burning patients.

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

Augmentation devices failed bacterial endotoxin testing.

Augmentation devices failed bacterial endotoxin testing.

Augmentation devices failed bacterial endotoxin testing.

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.

Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.