Agency classClass IIOur severity:Low FDA (Devices)·Z-0763-2018·Announced 2018-03-07

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

Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and ink transfer to 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 1/5 (Low).

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

Our severity reasoning: The source text explicitly describes the issue as causing 'cosmetic defects' and 'transference of the ink,' which aligns with the rubric criteria for cosmetic defects and packaging-only problems.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temp 13"x18" Self Seal Pouches (Model# 884118, Lot# 161230A and #170230A). The recall involves 78 units distributed nationwide in the United States.

The recall was initiated on June 15, 2017, 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 purchased these specific lots should stop using the affected pouches and contact Steris Corporation for further instructions or a refund. The issue is limited to cosmetic defects and ink transfer; the source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: Vis-U-All High Temp 13"x18" Self 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…
Manufacturer: Steris Corporation
Category: Medical Device — Sterilization Pouches
Hazard: cosmetic-defect
ink-migration
Affected units: 78

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# 884118 Lot# 161230A and #170230A

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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