Z-0771-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- June 15, 2017
- Termination Date
- July 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81
Product Description
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model# 884816 Lot# 161238A and #170238A