Z-0153-2016Class II

OneTray Sealed Sterilization Containers

Name: Z-0153-2016 OneTray Sealed Sterilization Containers
Creator: Innovative Sterlization Technologies LLC
Published: 2014-02-03
License: https://open.fda.gov/license/

Innovative Sterilization Techn / initiated 2014-02-03 / Terminated / root cause: manufacturing process

FDA source

Innovative Sterlization Technologies LLC began a recall of OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices on 2014-02-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0153-2016
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Posted: 2015-10-22
Terminated: 2016-02-04
Recalling firm: Innovative Sterilization Techn
Product: OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), [email protected]
Quantity in commerce: M2104 - 25 units; M2408 - 84 units
Distribution: US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
Product codes and lots: M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0153-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21

Product code KCT

K052567Class IIOne Tray Sealed Sterilization ContainerSterile Containment Technology, LLC / cleared 2006-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)