The Recall Desk
ModerateFDA (Devices)·Z-0757-2018·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.

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, and the identified hazard is primarily cosmetic defects and ink transfer, which aligns with the rubric for moderate severity involving minor labeling or cosmetic issues without reported serious injuries.

Plain-English summary

Steris Corporation is recalling specific lots of Vis-U-All High Temperature Sterilization Pouches. The recall involves 55 cases of the 6"x10" pouches, with 200 pouches per box and 5 boxes per case. The affected products are identified by Model #883610 and Lot #161124A and #170224A. These pouches were distributed nationwide in the United States.

The recall was initiated 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. The pouches are designed to maintain the sterility of properly processed medical devices during handling and storage.

Healthcare providers who have purchased these specific lots should stop using them and contact Steris Corporation for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could 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 6"x10" 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 designed
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Pouches
Hazard
Affected units
55

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# 883610 Lot# 161124A and #170224A

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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