Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris 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 hazard is limited to cosmetic defects and ink transfer, with no reported injuries or adverse health consequences.
Plain-English summary
Steris Corporation is recalling Vis-U-All High Temp 4.5"x11" Heat Seal Pouches. The recall involves 127 units of the product, specifically Model# 883411 and Lot# 161121A. These pouches are designed for healthcare providers to enclose and seal medical devices for steam sterilization.
The recall was initiated after Steris identified that the purple ink on the outside label of the pouches 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 products were distributed nationwide in the United States. Healthcare providers and consumers should stop using the recalled pouches and contact Steris Corporation for further instructions on how to proceed.
The recalled product
- Product
- Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 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 designe
- Manufacturer
- Steris Corporation
- Affected units
- 127
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# 883411 Lot# 161121A
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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