The Recall Desk
ModerateFDA (Devices)·Z-0752-2018·Announced 2018-03-07

Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

Steris Corporation is recalling Vis-U-All High Temp Heat Seal 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

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly limits the hazard to 'cosmetic defects' and ink transference, with no reports of injury or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temp 13"x18" Heat Seal Pouches (Model# 883118, Lot# 161119A) distributed nationwide in the United States. The recall was initiated after the company 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. The pouches are designed to enclose and seal medical devices for steam sterilization and to maintain sterility during handling and storage.

Healthcare providers who have purchased or are using these specific pouches should stop using them and contact Steris Corporation for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 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
4

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# 883118 Lot# 161119A

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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Same hazard · ink migration

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