Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris 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
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly identifies the issue as causing 'cosmetic defects' and ink transfer, with no mention of adverse health consequences, injury, or illness, aligning with the criteria for a Low severity score.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches (Model# 881121, Lot# 161109A) due to a defect in the purple ink used on the exterior labels. The product is used by healthcare providers to enclose and seal medical devices for steam sterilization.
On June 15, 2017, Steris identified that the purple ink 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 recall affects 10 units distributed nationwide in the United States. Healthcare providers should stop using the affected pouches and contact Steris Corporation for further instructions.
The recalled product
- Product
- Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6 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
- Affected units
- 10
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# 881121 Lot# 161109A
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.
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