The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0761-2018·Announced 2018-03-07

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

Steris Corporation 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 source text explicitly describes the issue as causing 'cosmetic defects' and 'transference of the ink,' which aligns with the rubric's criteria for Moderate severity involving minor labeling errors or low-risk contamination without reported serious injury.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches, specifically the 3.5"x9" Self Seal Pouch model 884039. The recall affects 139 units distributed nationwide in the United States. The specific lots involved are 161228A and 170228A.

The recall was initiated after Steris identified on June 15, 2017, 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 purchased these specific lots should stop using the affected pouches and contact Steris Corporation for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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…
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
139

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# 884039 Lot# 161228A and #170228A

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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