AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
Reported: November 6, 2024 Initiated: September 26, 2024 #Z-0269-2025
Product Description
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
Reason for Recall
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.
Details
- Recalling Firm
- King Systems Corp. dba Ambu, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420. Recalled by King Systems Corp. dba Ambu, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0269-2025.
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