Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Numb...
FDA Recall #Z-0790-2021 — Class II — December 2, 2020
Product Description
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
Reason for Recall
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) 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
Recalling Firm
Steris Corporation — Mentor, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
53 cases
Distribution
Nationwide Foreign:
Code Information
Lot Number: 200421A, 200521A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated