KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent
Summary
The FDA issued a Class II for KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s phary by King Systems Corp. dba Ambu, Inc.. Reason: 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
Source
Device Recall
External ID
Z-0275-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UD-DI: 00612649212722 (Shipper Label); 00612649212739 (Piece Label)
Quantity Affected: 44755 units
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.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-26
Company
Noblesville, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
King Systems Corp. dba Ambu, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (King Systems Corp. dba Ambu, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does King Systems Corp. dba Ambu, Inc. have FDA actions?
King Systems Corp. dba Ambu, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0275-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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