Reported Oct 2, 2024 · Ongoing

eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

T.G. Eakin Limited

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: T.G. Eakin Limited · 15 Ballystockart Road · Comber · N/A

Is this the product you have?

  • eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Lot codes and dates
    • UDI/DI 00768455108732
    • Lot number 109357C553
Amount recalled
35,400 cartons of 20 individually packaged seals

Where it was sold

Why it was recalled

On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.