Reported Mar 7, 2018 · Terminated
Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4
- boxes per case Product UsageThe 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 to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use
- Lot codes and dates
- Model# 884128 Lot# 161232A
- Amount recalled
- 12
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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