Z-3263-2024 Class III Ongoing

Recalled by T.G. Eakin Limited — Comber

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