Class 2 Device Recall YOUNG DH Dry Heat Indicators

• Date Initiated by Firm: December 29, 2021
• Create Date: February 02, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0555-2022
• Recall Event ID: 89330
• 510(K)Number: K890761
• Product Classification: Indicator, physical/chemical sterilization process - Product Code JOJ
• 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 process.
• Code Information: Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
• Recalling Firm/ Manufacturer: Young Dental Mfg Co I LLC; 13705 Shoreline Ct E; Earth City MO 63045-1202
• For Additional Information Contact: Jose Espino; 224-622-7191
• Manufacturer Reason for Recall: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 158 units
• Distribution: US Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JOJ