Ambu / King Ltsd recall
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…
Why was Ambu / King Ltsd 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00612649210131 (Shipper Label); 00612649210148 (Piece Label)
- Product
- 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…
- Recalling firm
- King Systems Corp. dba Ambu, Inc.
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)