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Defective software media distributed with upgrade software may cause installation failure and systems lock.
Sterility cannot be assured
Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
Instrument is excessively flexible making it unusable by the surgeon.
Non sterile device is labeled sterile.
Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm
Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Version 2.6 software was released however it will not properly handle adjustment slopes.
Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
The Calibrator included within the kit may be losing reactivity.
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
Product was found to produce higher recoveries by about 7-12% compared to other lots.
Product may not be sterile.
Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.