Medical equipment, implants, and diagnostic devices
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Synthes (USA) Products
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
Smith & Nephew
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
Synthes (USA) Products
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.