Device product
Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
Z-0786-2021
Product summary
- Event
- Event 86942
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 cases
- Official record key
device-enforcement:Z-0786-2021
Official wording
Reason: 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
Code information: Lot Number: 200505A
Distribution pattern: Nationwide Foreign:
Derived failure modes
-
Unknown
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