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IV sets may leak.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Lack of Assurance of Sterility
May contained undeclared almond
Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.
The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
Wound dressing may have foreign matter on the product.
Product does not declare wheat in the allergen statement.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Failed Impurities/Degradation Specifications: