Steris Corporation recalls Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Tem…

Recall date

June 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0752-2018

FDA classification

Class II

Brand / firm

Steris Corporation

Sold / distributed

US Nationwide Distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 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.