Rhode Island recalls

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

The recalled bed rails violate the mandatory standard for children's portable bed rails because, when installed adjacent to the bed, the child can become entrapped in the enclosed openings, the openings on the side of the mattress, and the openings on top of the mattress, posing a risk of serious injury or death due to entrapment.

The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire.

The pump's canister can forcefully eject from the base when pressurized, posing a risk of serious injury from impact to the user or bystander.

The recalled bed rails violate the mandatory standard for adult portable bed rails, posing a serious entrapment hazard and risk of death by asphyxiation. When the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. In addition, the bed rails do not have the required warning labels.

The recalled toys are intended for children under three years of age and the eyes can detach, which violates the small parts ban, posing a choking hazard to children.

The swings were marketed for infant sleep and have an incline angle greater than 10 degrees, violating the mandatory safety standard for Infant Sleep Products and the ban on inclined sleepers under the Safe Sleep for Babies Act, posing a deadly suffocation risk.

The recalled nightgowns violate the mandatory flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The fan wheel inside the backpack blower can break apart, posing a laceration hazard.

The recalled infant bath tubs violate the mandatory standard for consumer products containing button cell or coin batteries because the built-in thermometer contains button cell batteries that can be accessed easily by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The left front wheel can detach during use, posing a fall hazard.

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, posing a deadly entrapment hazard. Babies can suffocate 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 non-full-sized crib mattress also fails to meet the mandatory standard for mattress set flammability.

The bike's seat post assembly can break during use, posing fall and injury hazards to the user.

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.