Ostomy barrier seals recalled for blistering and incorrect model labeling
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Blistering of ostomy barrier seals presents a risk-of-harm to users without reported incidents. This FDA Class III recall involves functional defects without demonstrated injury, meeting the rubric criterion for High (3) severity.
Plain-English summary
T.G. Eakin Limited is recalling 35,400 cartons of eakin Cohesive small seals (Model Number 839002), an ostomy barrier product distributed in Kentucky. The affected lot (109357C553) contains blistered seals that are labeled as Model Number 839005 instead of 839002.
Ostomy barrier seals are critical medical devices that must seal properly. Blistering on these seals may compromise their adhesion and protective function.
Consumers who have received affected seals should stop using them and contact T.G. Eakin Limited or their healthcare provider for replacement. The recalled lot can be identified by lot number 109357C553 and UDI/DI 00768455108732.
The recalled product
- Product
- eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
- Manufacturer
- T.G. Eakin Limited
- Category
- Medical Device — Ostomy Barrier
- Hazard
- blistering
- mis-labeling
- seal-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00768455108732
- Lot number 109357C553
Distribution
Distributed in 1 state:
- KY
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