Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult

FDA device recall Z-1383-2025 · posted 2025-03-17 · Open, Classified

Recall details

Recalling firm

Oridion Medical 1987 Ltd.

Reason for recall

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.

Action taken

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.

Root cause

Labeling design

Status

Open, Classified

Product code

CCK

Quantity affected

62877

Distribution

Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ, KY, AR, TN, MO, DE, MA, MS, UT, DC, NE, IA, WV, NJ, KS, LA

Date initiated

2025-02-17

Date posted

2025-03-17

Location

Jerusalem, Har Hotzvim Industrial Park, Israel

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