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.
FDA Recall Z-0555-2022 · Posted None
Advertisement
Recalling FirmYoung Dental Mfg Co I LLC
Recall StatusOpen, Classified
Product CodeJOJ
Date Initiated2021-12-29
Product Quantity158 units
Reason for Recall
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels
instead of Dry Heat Indicator Labels.
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: [email protected] 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: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement