Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
The nut holding the blender blade assembly can loosen and detach from the base when in use, posing a laceration hazard if a consumer comes in contact with a loose blade.
The seam on the activity toy's house can open, allowing a young child access to the toy's filling, posing choking and ingestion hazards if placed in the mouth.
The utility vehicle's steering shaft can shear at or near the electric power steering housing, and cause the driver to lose steering control, posing injury and collision hazards.
The recalled products can contain bacteria, including Burkholderia cepacia complex, Klebsiella aerogenes and multiple different species of Pseudomonas, many of which are environmental organisms found widely in soil and water, and some may also be found in humans. People with weakened immune systems, external medical devices, and underlying lung conditions who are exposed to the bacteria face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, or through the eyes or a break in the skin. People with healthy immune systems are usually not affected by the bacteria.