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Some of the recalled catheters may be in pouches with incomplete seals.
Plastic insert over articular surface of knee joint replacement may become dislodged.
Kits had parts in them that did not belong in the kit.
Complaints of prolonged clot times.
Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
Separation of the sensing element from the body of the electrode.
The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.
Kits are missing the temporary arteriotomy locator (TAL) from the blister package.
Lack of assurance of reliability.
The label is missing the Rx Only symbol.
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
Software Design Defect. Under certain conditions, results are removed.
Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.
Test Strips may not be meeting specifications at the lower range of glucose values.