The Recall Desk
LowFDA (Devices)·Z-0787-2021·Announced 2021-01-13

Steris Vis-U-All High Temperature Tubing Recalled for Ink Migration

Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

What this means for you

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 ink transference, which aligns with the rubric criterion for cosmetic defects and packaging-only problems.

Plain-English summary

Steris Corporation is recalling 65 units of Vis-U-All High Temperature Tubing, Model Number 881041. The product is identified by Lot Number 200406A and was distributed nationwide and to foreign locations.

The recall was initiated because purple ink located on the outside label of the Vis-U-All 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 devices contained within the pouch.

The source text does not specify specific actions for consumers or end-users beyond the recall notice. No illnesses or injuries are reported in the source text.

The recalled product

Product
Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
Manufacturer
Steris Corporation
Affected units
65

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)

  • Lot Number: 200406A

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 →