Recall Z-0153-2016 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Innovative Sterlization Technologies LLC
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
| Date | Oct 22, 2015 (initiated Feb 3, 2014) |
| Status | Terminated |
| 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. |
| 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), dbillman@ISTSterilization.com |
| Quantity | M2104 - 25 units; M2408 - 84 units |
| Distribution | US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052567 | ONE TRAY SEALED STERILIZATION CONTAINER Sterile Containment Technology, LLC, Mar 13, 2006 |