Young Dental Sterilization Indicator Labels May Contain Wrong Type
YOUNG DH Dry Heat Indicator Labels used in healthcare sterilization may contain TTS Indicator Labels instead. Healthcare providers should verify package contents before use to ensure proper sterilization monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where packaging may contain incorrect sterilization indicator type. While no injuries have been reported, wrong indicators could compromise sterilization monitoring in healthcare settings, creating a risk of harm to patient safety.
Plain-English summary
Young Dental Manufacturing is recalling YOUNG DH Dry Heat Indicator Labels (Reference 116312, Lot Number 165892) distributed in the United States. Packaging for these sterilization monitoring labels may contain TTS Indicator Labels instead of the intended Dry Heat Indicator Labels.
These indicators are used by healthcare providers to monitor the sterilization process of medical instruments during dry heat sterilization procedures. Using the wrong type of indicator could result in improper monitoring of sterilization parameters, potentially compromising the effectiveness of the sterilization process.
Healthcare providers who have received this product should verify the contents of their packages before use. If the incorrect indicator type is found, contact Young Dental Manufacturing for replacement product.
The recalled product
- 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…
- Manufacturer
- Young Dental Mfg Co I LLC
- Affected units
- 158
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Distribution
Distribution scope not specified by the agency.
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