Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches 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 notes that no illnesses or injuries have been reported, fitting the rubric criteria for cosmetic defects and packaging-only problems.
Plain-English summary
Steris Corporation is voluntarily recalling Vis-U-All High Temp 7.5"x13" Self Seal Pouches, Model Number 884713. The recall involves 201 cases, with 200 pouches per box and 4 boxes per case. The affected lot numbers are 200437A and 200637A. The product was distributed nationwide and to foreign locations.
The recall was initiated because purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This issue causes cosmetic defects on the exterior of the pouch. In some instances, the ink may transfer onto the medical devices contained within the pouch.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall. Users 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 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713
- Manufacturer
- Steris Corporation
- Affected units
- 201
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 (2)
- Lot Number: 200437A
- 200637A
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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