Class 2 Device Recall Microstream Advance NeonatalInfant Intubated CO2 Filter Line

• Date Initiated by Firm: February 17, 2025
• Date Posted: March 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1382-2025
• Recall Event ID: 96309
• 510(K)Number: K181467
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
• Code Information: Part Number and Revision - REF/UDI-DI(Lot): PT00134354 Rev A- QMVIIH/10884521762374(C210314316, C211085494)
• FEI Number: 3001227743
• Recalling Firm/ Manufacturer: Oridion Medical 1987 Ltd.; Har Hotzvim Industrial Park Box 45025; Har Hotzvim Industrial Park; Jerusalem Israel
• For Additional Information Contact: Technical Support; 800-2556774
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• Action: 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.
• Quantity in Commerce: 350
• 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, WA, HI, MN, AL, ME, RI, OK, MT, ID, CT, NH, AK, NV, SD, WY, ND, NM and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Northern Ireland, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Virgin Islands, U.S.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CCK