Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Research enforcement Z-1313-2026 in seconds
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Enforcement
- Recall Number
- Z-1313-2026
- Event ID
- 98285
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 18, 2026
- Initiation Date
- December 24, 2025
- Classification Date
- February 6, 2026
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Distribution US nationwide and Canada.
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