Recall Z-0153-2016— Innovative Sterlization Technologies LLC

Name: FDA recall Z-0153-2016
Creator: U.S. Food and Drug Administration
Published: 2014-02-03

Class II · Terminated

Class II FDA medical device recall by Innovative Sterlization Technologies LLC, initiated 2014-02-03, terminated 2016-02-04. It names one FDA 510(k) clearance: K052567. Product: OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices. Reason: The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F..

Recalling firm: Innovative Sterlization Technologies LLC
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Terminated: 2016-02-04
Firm location: Dayton, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K052567 — ONE TRAY SEALED STERILIZATION CONTAINERSterile Containment Technology, LLC·cleared 2006-03-13

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

OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

Reason for recall

The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.

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