Steris Recalls Vis-U-All Heat Seal 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 describes the issue 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 8"x16" Heat Seal Pouches (Model# 883816, Lot# 161127A) due to a defect in the purple ink used on the exterior labels. The recall was initiated after the company identified that the ink may migrate following steam processing.
This migration can cause cosmetic defects on the exterior of the pouch and, in some instances, result in the transfer of ink onto the medical devices contained within. The affected product is distributed nationwide in the United States.
Healthcare providers should stop using the affected pouches and contact Steris Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 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
- 9
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# 883816 Lot# 161127A
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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