YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a
Summary
The FDA issued a Class II for YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STR by Young Dental Mfg Co I LLC. Reason: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels..
Details
Source
Device Recall
External ID
Z-0555-2022
Action Date
2022-02-09
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Quantity Affected: 158 units
Reason for Recall
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Distribution
US Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-29
Company
Earth City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Young Dental Mfg Co I LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Young Dental Mfg Co I LLC have FDA actions?
This is the only FDA action we have on record for Young Dental Mfg Co I LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0555-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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