Cardinal Health 200, LLC: Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cardinal Health 200, LLC
- Product
- Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
- Reason / hazard
- Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Pending
- Recall initiated
- 2026-08-19
- Code info
- AN23366084 UDI-DI 10197106950074 Kit lot 40711 AN23366085 UDI-DI 10198956177987 Kit lot 46520 AN2336608H UDI-DI 10197106159828 Kit lots 20866 23139 24264 25795 27111 27899 29023 29488 30527 31037 31698 32777 33326 AN2336608J UDI-DI 10197106704035 Kit lots 33461 33624 35231 35535 35689 36554 36600 36825 38327 38891 40511 41864 43975 44933 45972 47547 47897 48088 48528 49440 OMSVM4166A UDI-DI 10198956162259 Kit Lots 47765 50521 53221 53929 54565 54644 AN2336608G UDI-DI 10197106052105 Kit lots 18464 18569 19224
- Product quantity
- 210 total kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukegan
- State
- IL
- Country
- United States
- Event id
- 99801
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