Recall Z-0797-2021 ยท FRG Wrap, Sterilization
Steris Corporation
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515
| Date | Dec 2, 2020 |
| Status | Terminated |
| Reason | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch |
| Root cause | Process control |
| Action | Steris issued Urgent Medical Device Recall issued 12/2/20 to Distributors and Customers. Letter states reason for recall, health risk and action to take: 1.Please immediately inspect on-hand inventory for Vis-U-All High Temperature Sterilization Pouches and Tubing. For the full list of affected product and associated lots, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this Customer Notification Letter and destroy any remaining product in inventory. STERIS will coordinate shipment of replacement product upon receipt of th |
| Quantity | 7 cases |
| Distribution | Nationwide Foreign: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Safe Secure Packaging Co., Ltd., Aug 4, 2016 |