# FDA recall Z-0761-2018

> **Steris Corporation** · Class II · device recall initiated 2017-06-15.

## Product

Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 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 and the medical device is removed for use.

## Reason for recall

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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0761-2018
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2018-03-07
- **Termination date:** 2018-07-17

- **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-0761-2018

## Citation

> AI Analytics. FDA recall Z-0761-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0761-2018. Source: US FDA. Licensed CC0.

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