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Recall Observatory FDA recall evidence

Device product

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.

Z-0555-2022

December 29, 2021

Class II

Product summary

Firm
Young Dental Mfg Co I LLC
Event
Event 89330
Status
Ongoing
Classification
Class II
Quantity
158 units
Official record key
device-enforcement:Z-0555-2022

Official wording

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

Code information: Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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