Date Initiated by Firm | September 26, 2024 |
Date Posted | October 30, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0270-2025 |
Recall Event ID |
95451 |
Product Classification |
Airway, oropharyngeal, anesthesiology - Product Code CAE
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Product | KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD421 |
Code Information |
UDI-DI:
00612649210162 (Shipper Label); 00612649210155 (Piece Label)
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Recalling Firm/ Manufacturer |
King Systems Corp. dba Ambu, Inc. 15011 Herriman Blvd Noblesville IN 46060-4253
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For Additional Information Contact | Sanjay Parikh 1-800-2628462 |
Manufacturer 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. |
FDA Determined Cause 2 | No Marketing Application |
Action | King Systems issued Urgent Field Safety Notice on 9/26/624 via email/Certified Mail. Letter states reason for recall, health risk and action to take:
You must discontinue use and dispose of King LTS-D" Disposable Laryngeal Tube pediatric sizes and identify alternative devices for appropriate airway management.
Within one month of receipt of this notice, please provide return response for this Field Safety Notice.
This Notice needs to be passed on to all those who might concern within your organization where the devices could have been transferred.
Please transfer this notice to other organizations on which this action has an impact.
Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Patient safety remains our highest priority. If you have additional questions regarding this information, please contact your local Ambu-King Systems sales representative.
Should you have additional questions, please do not hesitate to contact Tammy Feyerherm at tfey@ambu.com. |
Quantity in Commerce | 21939 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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