Agency classClass IIOur severity:Low FDA (Devices)·Z-0755-2018·Announced 2018-03-07

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

Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential 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 recall is classified as Low severity because the hazard is limited to cosmetic defects and ink transfer, which are packaging-only problems with no reported adverse health consequences.

Plain-English summary

Steris Corporation is recalling Vis-U-All High Temp 3.5"x22" Heat Seal Pouches. The recall involves 17 units of Model# 883422, Lot# 161122A, which were 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 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 pouches should stop using them and contact Steris Corporation for further instructions. The issue is limited to the cosmetic appearance of the pouch and potential ink transfer, with no reported injuries or illnesses associated with the defect.

The recalled product

Product: Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 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: 17

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# 883422 Lot# 161122A

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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