King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption
King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites a regulatory compliance issue (exceeding 510(k) exemption limitations) rather than a specific physical defect or reported injury, aligning with the 'Moderate' severity criteria for voluntary or regulatory-driven recalls without reported harm.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD, Size 2, with Suction Port Sterile Oropharyngeal Airways (Model/Catalog Number: KLTSD422). These devices are inserted into a patient's pharynx through the mouth to provide a patent airway. The recall is nationwide.
The recall was initiated because the device exceeds the limitations to the 510(k) exemption in 21 CFR 868.9(a). Specifically, the device introduces a new indication for pediatric use in an Oropharyngeal Airway, which requires further regulatory review.
Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on return or replacement. The affected units are identified by UD-DI codes 00612649210186 (Shipper Label) and 00612649210179 (Piece Label).
The recalled product
- Product
- KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Affected units
- 42,605
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)
- UD-DI: 00612649210186 (Shipper Label)
- 00612649210179 (Piece Label)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by King Systems Corp. dba Ambu, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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