Steris Vis-U-All Pouches Recalled for Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate 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 recall is classified as FDA Class II, but the source text explicitly describes the hazard as 'cosmetic defects' and ink transference, with no mention of injury, illness, or functional failure. This aligns with the rubric for cosmetic defects and packaging-only problems.
Plain-English summary
Steris Corporation is voluntarily recalling 589 cases of Vis-U-All High Temp 13"x18" Self Seal Pouches, Model Number 884118. The recall is due to purple ink located on the outside label of the pouches, which may migrate or bleed following steam processing.
This migration can cause cosmetic defects on the exterior of the pouch and, in some instances, result in the transference of the ink onto the medical devices contained within the pouch. The affected product is identified by Lot Number 200430A and was distributed nationwide and to foreign locations.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop use or return the product. Users should refer to the official FDA recall notice or contact the manufacturer for specific instructions regarding the affected lot.
The recalled product
- Product
- Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
- Manufacturer
- Steris Corporation
- Affected units
- 589
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: 200430A
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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