FDAFDA · Food and drugs·Recall number Z-0275-2025
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
Published November 6, 2024 · Recall initiated: September 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Distributor
- Nationwide
- Lot
- UD-DI: 00612649212722 (Shipper Label); 00612649212739 (Piece Label)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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