Recall Z-0555-2022— Young Dental Mfg Co I LLC

Name: FDA recall Z-0555-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-29

Class II · Ongoing

Class II FDA medical device recall by Young Dental Mfg Co I LLC, initiated 2021-12-29. It names one FDA 510(k) clearance: K890761. 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.. Reason: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels..

Recalling firm: Young Dental Mfg Co I LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-12-29
Firm location: Earth City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K890761 — STRIP, STERILIZATION INDICATOR; DRY HEATSpsmedical Supply Corp.·cleared 1989-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.