Recall Z-0765-2018 ยท FRG Wrap, Sterilization
Steris Corporation
Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened
| Date | Jun 15, 2017 |
| Status | Terminated |
| Reason | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate 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 | Component change control |
| Action | Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873. |
| Quantity | 12 |
| Distribution | US Nationwide Distribution |
| 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 |