Device product
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Z-3263-2024
Product summary
- Event
- Event 95241
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 35,400 cartons of 20 individually packaged seals
- Official record key
device-enforcement:Z-3263-2024
Official wording
Reason: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
Code information: UDI/DI 00768455108732, Lot number 109357C553
Distribution pattern: US: KY
Derived failure modes
-
Unknown
On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.