[pending] Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Pending LLM rewrite. Source: FDA_DEVICE Z-1312-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Distribution
Distributed nationwide across the United States.
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