King LTS-D Kit Size 1 Recalled for Incorrect Packaging and Labeling
King Systems Corp. dba Ambu, Inc. is recalling 270 King LTS-D Kit Size 1 units because they were incorrectly packaged and labeled as size 1 products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling/packaging error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling 270 units of the King LTS-D Kit Size 1, Model Number KLTSD431. The recall was initiated because the products were incorrectly packaged and labeled as size 1 products, although the source text notes that size 0 products were the ones incorrectly packaged and labeled as size 1.
The affected products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI. The specific lot code for the recalled items is 1000147351.
Consumers who have purchased or received these products should stop using them and contact the recalling firm for instructions on how to return or dispose of the items. This recall is classified as Class II by the FDA.
The recalled product
- Product
- King LTS-D Kit Size 1, Model Number KLTSD431
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Affected units
- 270
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 (1)
- Lot code 1000147351
Distribution
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