The Recall Desk
ModerateFDA (Devices)·Z-1681-2019·Announced 2019-06-05

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.

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 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
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

Distributed in 11 states: