Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the outside label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly describes the issue as causing 'cosmetic defects' and ink transfer without reporting any injuries or illnesses. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination where no harm has been reported.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temperature Tubing, Model Number 881061, due to a labeling defect. The product is packaged as one roll per box, with 10 boxes per case. The recall involves 98 cases, with lot numbers 200407A and 200707A. The product was distributed nationwide and to foreign locations.
The recall was initiated because purple ink located on the outside label of the Vis-U-All Pouches may migrate or bleed following steam processing. This issue causes cosmetic defects on the exterior of the pouch and, in some instances, results in the transference of the ink onto the medical devices contained within the pouch.
This is a Class II recall. The hazard is primarily cosmetic and involves potential ink transfer to devices, but the source text does not report any illnesses, injuries, or deaths associated with this defect. Users should stop using the affected tubing and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
- Manufacturer
- Steris Corporation
- Affected units
- 98
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: 200407A
- 200707A
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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