Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Heat Seal 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 source text explicitly describes the issue as causing 'cosmetic defects' and 'transference of the ink,' 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 4"x8" Heat Seal Pouches (Model # 883048, Lot # 161116A). The recall involves 32 cases, with 5 boxes per case and 200 pouches per box. These products were distributed nationwide in the United States.
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 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 pouch.
Healthcare providers who have purchased these specific pouches should stop using them and contact Steris Corporation for further instructions. The pouches are designed to enclose and seal medical devices for steam sterilization, but the ink migration issue affects the exterior label and potentially the devices inside.
The recalled product
- Product
- Vis-U-All High Temp 4"x8" 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 designed t
- Manufacturer
- Steris Corporation
- Affected units
- 32
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# 883048 Lot# 161116A
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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