Z-3263-2024 Class III Ongoing
FDA device recall Z-3263-2024 was initiated by T.G. Eakin Limited on August 8, 2024 and is designated Class III. Reason for recall: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. The recall status is ongoing. Affected quantity: 35,400 cartons of 20 individually packaged seals.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,400 cartons of 20 individually packaged seals
Product Description
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Reason for Recall
On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
Distribution Pattern
US: KY
Code Information
UDI/DI 00768455108732, Lot number 109357C553