OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical d
FDA device recall Z-0153-2016 · posted 2015-10-22 · Terminated
Recall details
- Recalling firm
- Innovative Sterlization Technologies LLC
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- M2104 - 25 units; M2408 - 84 units
- Distribution
- US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
- Date initiated
- 2014-02-03
- Date posted
- 2015-10-22
- Date terminated
- 2016-02-04
- Location
- Dayton, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE TRAY SEALED STERILIZATION CONTAINER (K052567) | Sterile Containment Technology, LLC | 2006-03-13 |