FDA recall Z-3263-2024

T.G. Eakin Limited · Class III · device

Product

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

US: KY

Key facts

Status: Ongoing
Initiation date: 2024-08-08
Report date: 2024-10-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Comber, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3263-2024