PlainRecalls
FDA Devices Moderate Class II Terminated

Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

Reported: January 13, 2021 Initiated: December 2, 2020 #Z-0791-2021

Product Description

Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

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

Details

Recalling Firm
Steris Corporation
Units Affected
54 cases
Distribution
Nationwide Foreign:
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610. Recalled by Steris Corporation. Units affected: 54 cases.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0791-2021.