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U.S. Department of Health and Human Services

Class 2 Device Recall YOUNG DH Dry Heat Indicators

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  Class 2 Device Recall YOUNG DH Dry Heat Indicators see related information
Date Initiated by Firm December 29, 2021
Create Date February 02, 2022
Recall Status1 Open3, 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 2		 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 and Original Applicant = SPS MEDICAL SUPPLY CORP.
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