FDA Medical devices recall ·
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient… recall
- Recall number
- Z-0276-2025
- Date
- (initiated September 26, 2024)
- Company / brand
- Ambu
15011 Herriman Blvd, Noblesville, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36727 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UD-DI: 00612649212746 (Shipper Label); 00612649212753 (Piece Label)
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0276-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.