The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0793-2021·Announced 2021-01-13

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

Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

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 recall is classified as FDA Class II, but the hazard is limited to cosmetic defects and ink transfer without reported injuries or serious health risks, fitting the Moderate category for minor labeling or cosmetic issues.

Plain-English summary

Steris Corporation is voluntarily recalling Vis-U-All High Temp 3.5"x9" Self Seal Pouches, Model Number 884039. The recall involves 170 cases, with lot numbers 200428A and 200628A. The product was distributed nationwide and to foreign locations.

The recall is due to a defect where purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This issue causes cosmetic defects on the exterior of the pouch and, in some instances, results in the transference of the ink onto the medical devices contained within the pouch.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected pouches and contact Steris Corporation for further instructions or a refund.

The recalled product

Product
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
170

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 (2)

  • Lot Number: 200428A
  • 200628A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

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