The Recall Desk
LowFDA (Devices)·Z-0771-2018·Announced 2018-03-07

Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as Low severity because the hazard is limited to cosmetic defects and ink transfer, with no reported injuries or adverse health consequences.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches (Model # 884816, Lot # 161238A and #170238A). The recall involves 81 units distributed nationwide in the United States. These pouches are used by healthcare providers to enclose and seal medical devices for steam sterilization.

The recall was initiated after Steris identified that the purple ink on the outside label of the pouches may migrate following steam processing. This migration can cause cosmetic defects on the exterior of the pouch and, in some instances, result in the transfer of ink onto the medical devices contained within the pouch.

Healthcare providers who have these specific lots of Vis-U-All pouches should stop using them and contact Steris Corporation for further instructions. The issue is limited to the exterior label ink and does not indicate a failure of the pouch's ability to maintain sterility, but the ink transfer may affect the appearance of the sterilized devices.

The recalled product

Product
Vis-U-All High Temp 8"x16" 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
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
81

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model# 884816 Lot# 161238A and #170238A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 29 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 29 products in this recall →

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