Recall Z-1266-2016 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
PMBS, LLC
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
| Date | Jan 13, 2016 |
| Status | Terminated |
| Reason | Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility. |
| Root cause | Device Design |
| Action | On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum |
| Quantity | 58 units |
| Distribution | FL, GA, MN, NY, OH, OR SC, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110898 | S.C.O.R.E.S. UNIT Ammed Surgical Equipment, LLC, Jul 26, 2012 |