Steris Vis-U-All Pouches Recalled for Ink Migration Defect
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during 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 describes 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 voluntarily recalling Vis-U-All High Temp 4"x11" Self Seal Pouches, Model Number 884411. The recall involves 43 cases of the product, which were distributed nationwide and to foreign locations. The specific lot number for the affected product is 200434A.
The recall is being issued because purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This defect causes cosmetic issues on the exterior of the pouch and, in some instances, results in the transference of ink onto the medical devices contained within the pouch.
This is a Class II recall. Consumers and healthcare facilities should stop using the affected pouches and contact Steris Corporation for further instructions or a refund.
The recalled product
- Product
- Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
- Manufacturer
- Steris Corporation
- Affected units
- 43
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: 200434A
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.
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