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Terminated

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

FDA Recall Z-0153-2016 · Posted 2015-10-22

Recalling FirmInnovative Sterlization Technologies LLC
Recall StatusTerminated
Product CodeKCT
Date Initiated2014-02-03
Date Terminated2016-02-04
Product QuantityM2104 - 25 units; M2408 - 84 units

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.

Firm 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]

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052567ONE TRAY SEALED STERILIZATION CONTAINERSterile Containment Technology, LLC · 2006-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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