# FDA recall Z-0797-2021

> **Steris Corporation** · Class II · device recall initiated 2020-12-02.

## Product

Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case							  Model Number: 884515

## Reason for recall

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

## Distribution

Nationwide  Foreign:

## Key facts

- **Recall number:** Z-0797-2021
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-02
- **Report date:** 2021-01-13
- **Termination date:** 2022-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2021

## Citation

> AI Analytics. FDA recall Z-0797-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0797-2021. Source: US FDA. Licensed CC0.

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