Device product
Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
Z-0787-2021
Product summary
- Event
- Event 86942
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-0787-2021
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: 200406A
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