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.

Company

Young Dental Mfg Co I Llc

Recall Initiated

December 29, 2021

Recall Number

Z-0555-2022

Quantity

158 units

Firm Location

Earth City, MO

Reason for Recall

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

Distribution

US Distribution

Lot / Code Info

Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892

Root Cause

Under Investigation by firm

Action Taken

The firm, Young Dental Manufacturing CO 1, LLC, initiated a "URGENT: MEDICAL DEVICE RECALL" letter dated 12/21/2021 on 12/29/2021 to its customers. The letter provided the reason for the recall and actions to be taken. The customers were instructed to discard or return product to Young Dental, provide additional information as applicable and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email: pwhaley@younginnovations.com or mail to: YOUNG DENTAL MANUFACTURING CO 1, LLC, 13705 Shoreline Ct E, Earth City, MO 63045. For further questions, contact VP, QRA at 224-622-7192 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time or email: jespino@younginnovations.com.