Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
The helmets do not comply with the positional stability, dynamic strength of retention system, impact attenuation, and certification requirements in violation of the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
The portable fuel containers do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child resistant, posing a risk of burns and poisoning to children.