FDA-Device2019-06-05Class II

King LTS-D Kit Size 1, Model Number KLTSD431

King Systems Corp. dba Ambu, Inc.
Hazard

Size 0 products were incorrectly packaged and labeled as a size 1 products.

Sold states
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
Affected count
270
Manufactured in
15011 Herriman Blvd, N/A, Noblesville, IN, United States
Products
King LTS-D Kit Size 1, Model Number KLTSD431

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2019

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