Medical Devices Recalls

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Hazard: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

Hazard: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

Hazard: There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

Hazard: There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

Hazard: It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

Hazard: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Hazard: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Hazard: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Hazard: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Hazard: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Hazard: Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.

Hazard: Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.

Hazard: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Hazard: Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation

Hazard: Affected lots of product may experience technical distortions to a greater extent than expected.

Hazard: Affected lots of product may experience technical distortions to a greater extent than expected.