eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Summary
The FDA issued a Class III for eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal by T.G. Eakin Limited. Reason: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005..
Details
Source
Device Recall
External ID
Z-3263-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Lot/Code Info: UDI/DI 00768455108732, Lot number 109357C553
Quantity Affected: 35,400 cartons of 20 individually packaged seals
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-08
Company
Comber
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (T.G. Eakin Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does T.G. Eakin Limited have FDA actions?
This is the only FDA action we have on record for T.G. Eakin Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3263-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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