Medical device recalls Moderate risk

Young Dental Mfg Co I LLC recalls YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a he…

Recall date
December 29, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0555-2022
FDA classification
Class II
Brand / firm
Young Dental Mfg Co I LLC
Sold / distributed
US Distribution

Why it was recalled

The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.

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

What was recalled

YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.

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