FDA recall Z-0797-2021

Product

Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515

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

Distribution

Nationwide Foreign:

Key facts

Status

Terminated

Initiation date

2020-12-02

Report date

2021-01-13

Termination date

2022-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2021