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Potential extended charge time anomalies.
Pouch containing pediatric probes was labeled as containing adult probes.
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
The device has the potential for tip breakage during use.
Sterility of product is compromised by open seals in packaging.
Wiring pin locking mechanism defective, potential to come apart in surgical site.
The kits were packaged with incorrect dispensing pipettes.
Outer kit mislabeled with an extended expiration date
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
Design Change
Kits may produce results that are falsely elevated.
Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
Sample wheel may home to the wrong position.
Mislabeled. 7mm balloon labeled 12mm
Sample values may be decreased by between 9 and 12 percent.
wrong product in box