Medical equipment, implants, and diagnostic devices
Philips Respironics
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Certain lots containing undersized dilator.
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Philips Respironics
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Certain lots containing undersized dilator.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Excessive ultraviolet-C radiation
Ortho-Clinical Diagnostics
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Medline Industries
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.