Medical device recalls Moderate risk

King Systems Corp. dba Ambu, Inc. recalls King LTS-D Kit Size 1, Model Number KLTSD431

Recall date
January 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1681-2019
FDA classification
Class II
Brand / firm
King Systems Corp. dba Ambu, Inc.
Sold / distributed
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

King LTS-D Kit Size 1, Model Number KLTSD431

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