Recall Z-3263-2024— T.G. Eakin Limited
Class III · Ongoing
Class III FDA medical device recall by T.G. Eakin Limited, initiated 2024-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal. Reason: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005..
- Recalling firm
- T.G. Eakin Limited
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Comber, Ireland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.