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The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
Mislabeled.
Wire braiding protruding from the catheter.
Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
A deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the Tracing Review screen when a user is acknowledging an Alert
Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.