Laryngeal Tube Device Recalled for Unapproved Pediatric Indication
King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm device (laryngeal tube for airway management) being used in a pediatric population for which it was not tested or cleared. No illnesses or injuries have been reported, but the unevaluated use in children meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
King Systems Corp., doing business as Ambu, Inc., is recalling 21,939 units of the KING LTSD (Laryngeal Tube with Suction Discharge), Size 1. This is a sterile medical device inserted through the mouth into the pharynx to establish and maintain an open airway.
The FDA issued this recall because the manufacturer introduced a new indication for pediatric use without obtaining proper regulatory clearance. The device was originally approved for adult patients. Under FDA regulations, introducing a new indication requires pre-market review and clearance, which was not obtained before pediatric use was marketed.
The recalled devices are distributed nationwide.
The recalled product
- 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
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- unapproved-indication
- pediatric-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00612649210162 (Shipper Label)
- 00612649210155 (Piece Label)
Distribution
Distributed nationwide across the United States.
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