FDA recall Z-0762-2018

Steris Corporation · Class II · device

Product

Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 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

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-06-15
Report date
2018-03-07
Termination date
2018-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0762-2018