The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
SunMed Holdings
14 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Surgical Instruments
Class I - Dangerous
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class I - Dangerous
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Class I - Dangerous
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Class I - Dangerous
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.