FDAFDA · Food and drugs·Recall number Z-0754-2018
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 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.
Published March 7, 2018 · Recall initiated: June 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- US Nationwide Distribution
- Lot
- Model# 883411 Lot# 161121A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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