Steris Recalls Vis-U-All Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
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 hazard 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 5.5"x10" Self Seal Pouches, Model Number 884510. The recall involves 229 cases of the product, which were distributed nationwide and to foreign locations. The specific lot numbers affected are 200435A and 200635A.
The recall was initiated because purple ink located on the outside label of the pouches may migrate or bleed following steam processing. This issue 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.
Healthcare facilities and consumers should stop using the affected pouches and contact Steris Corporation for further instructions or a refund. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
- Manufacturer
- Steris Corporation
- Affected units
- 229
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: 200435A
- 200635A
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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