FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0555-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0555-2022
- Event ID
- 89330
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Young Dental Mfg Co I LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 9, 2022
- Initiation Date
- December 29, 2021
- Classification Date
- February 2, 2022
- Address
- 13705 Shoreline Ct E, N/A, Earth City, MO, 63045-1202, United States
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
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Code Info
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Distribution
US Distribution
Quantity
158 units