Oridion Medical 1987 Ltd. Har Hotzvim Industrial Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

Recommended Action

Per FDA guidance

On 2/17/2025, correction notices were mailed to Risk Manager, Director of Respiratory Care, Director of Anesthesiology who were informed of the following: In September 2025, the firm will issue an update to the Instructions for Use (IFUs) for the The following IFU's: 01158, PT00156355, PT00156254, PT00156250 stating: Adverse events associated with attaching and detaching the airway adapter from the breathing circuit are listed in descending order of severity: unintended extubation, respiratory failure, hypoxia, low oxygen saturation, aspiration/inhalation and delay to treatment. Any serious incident related to device use that may occur should be reported immediately to the manufacturer, the local competent authority, and any other regulators as required. Pass on and post this notice for all those who need to be aware within your organization and to any organization where the affected product has been transferred or distributed. Complete and return the Customer Confirmation Form to rs.gmbmitgfca@medtronic.com Adverse reactions or quality problems experienced with this product should be reported to the firm's Quality Assurance at 800-255-6774 option 1, then option 1. If you have questions contact the firm's Customer Service at 800-962-9888, Option 2. On 5/13/2025, additional correction notices identifying additional affected devices were mailed to additional customers.