The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0745-2018·Announced 2018-03-07

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

Steris Corporation is recalling Vis-U-All High Temperature Tubing 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 recall is classified as FDA Class II, but the source text explicitly limits the hazard to cosmetic defects and ink transfer, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Steris Corporation is recalling 198 units of Vis-U-All High Temperature Tubing, Model # 881061, Lot # 161107A. The product is a sterilization pouch used by healthcare providers to enclose and seal medical devices for steam sterilization. The recall was initiated after the company identified that the purple ink on the outside label may migrate following steam processing.

This issue causes cosmetic defects on the exterior of the pouch and, in some instances, results in the transference of ink onto the medical devices contained within. The affected product was distributed nationwide in the United States.

Healthcare providers should stop using the affected product and contact Steris Corporation for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs 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
198

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# 881061 Lot# 161107A

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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