Medical Devices Recalls

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

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.

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.

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

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

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.

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.

Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

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.

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.

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

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.

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

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

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

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

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

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.

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

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery