Steris Recalls Vis-U-All Sterilization Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical 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 Low severity because the source text explicitly identifies the issue as causing 'cosmetic defects' and 'transference of the ink,' with no mention of injury, illness, or functional failure of the sterilization process.
Plain-English summary
Steris Corporation is voluntarily recalling Vis-U-All High Temperature Sterilization Pouches (Model #884122, Lot #161231A). The recall involves 39 units distributed nationwide in the United States. These pouches are used by healthcare providers to enclose and seal medical devices for steam sterilization.
The recall was initiated after Steris identified on June 15, 2017, that the purple ink on the outside label of the pouches may migrate following steam processing. This migration can result in cosmetic defects on the exterior of the pouch and, in some instances, the transfer of ink onto the medical devices contained within the pouch.
Healthcare providers who have purchased or received these specific pouches should stop using them and contact Steris Corporation for further instructions or a refund. The issue is limited to the exterior label ink and does not indicate a failure of the pouch's ability to maintain sterility, but the cosmetic defect and potential ink transfer necessitate the recall.
The recalled product
- Product
- Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed
- Manufacturer
- Steris Corporation
- Affected units
- 39
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)
- Model# 884122 Lot# 161231A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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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