FDA recall Z-0787-2021

Product

Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041

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-0787-2021