Filter, Bacterial, Breathing-circuit

Anesthesia circuit kit;

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

Medline Convenience kits labeled as:

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"