YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 ...
FDA Recall #Z-0555-2022 — Class II — December 29, 2021
Product Description
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.
Reason for Recall
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Recalling Firm
Young Dental Mfg Co I LLC — Earth City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
158 units
Distribution
US Distribution
Code Information
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated