Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects
Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies the issue as causing 'cosmetic defects' and ink transference, which aligns with the rubric criteria for cosmetic defects and packaging-only problems.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temp 4"x11" Self Seal Pouches. The recall involves 58 units, specifically Model# 884411 and Lot# 161234A, which were distributed nationwide in the United States.
The recall was initiated because 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, transfer ink onto the medical devices contained within the pouch.
Healthcare providers who have purchased these specific pouches should stop using them and contact Steris Corporation for instructions on how to return the product.
The recalled product
- Product
- Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 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
- Affected units
- 58
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# 884411 Lot# 161234A
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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