Device product
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
Z-0799-2021
Product summary
- Event
- Event 86942
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 cases
- Official record key
device-enforcement:Z-0799-2021
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: 200438A
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