Primary source: Swissmedic
Swissmedic published an Urgent Field Safety Notice (Recall) for One-Piece Guedel Airways due to the safety issue of occluded tips.
Use of affected devices may lead to respiratory distress, hypoxia, or neurological impairment when establishing a patent airway.
Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.
Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.
Swissmedic issued a Field Safety Notice for One-Piece Guedel Airways (Intersurgical, sizes 00 and 000) due to occluded tips. Required actions: identify, quarantine, return/destroy affected products, and complete reply form. Affected models: 1100050, 1100050S, 8100050, 1000035, 1000035S, 8000035; lots with expiry 2026-06 to 2031-02.
What changed: Swissmedic published an Urgent Field Safety Notice (Recall) for One-Piece Guedel Airways due to the safety issue of occluded tips.
Why it matters: Use of affected devices may lead to respiratory distress, hypoxia, or neurological impairment when establishing a patent airway.
Practical implication: Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.
Published from the Firecrawl agent regulatory extraction pipeline.
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