Recall Z-0555-2022 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Young Dental Mfg Co I LLC
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.
| Date | Dec 29, 2021 |
| Status | Open, Classified |
| Reason | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. |
| Root 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, co |
| Quantity | 158 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890761 | STRIP, STERILIZATION INDICATOR; DRY HEAT Spsmedical Supply Corp., Aug 7, 1989 |