FDA Device recall Z-0793-2021
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box by Steris, citing 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 ins….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0793-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-02 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Steris |
| Distribution | US |
Product
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
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
Identifiers
| code_info | Lot Number: 200428A, 200628A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0793-2021%22
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