FDA Device recall Z-0757-2018
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box by Steris, citing 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 ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0757-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-15 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Steris |
| Distribution | US |
Product
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 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 and the medical device is removed for use.
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.
Identifiers
| code_info | Model# 883610 Lot# 161124A and #170224A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0757-2018%22
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