Z-0555-2022 Class II Ongoing
FDA device recall Z-0555-2022 was initiated by Young Dental Mfg Co I LLC on December 29, 2021 and is designated Class II. Reason for recall: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. The recall status is ongoing. Affected quantity: 158 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158 units
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.
Distribution Pattern
US Distribution
Code Information
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892