| | Class 3 Device Recall Eakin Cohesive small seals |  |
| Date Initiated by Firm | August 08, 2024 |
|---|
| Date Posted | September 25, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3263-2024 |
|---|
| Recall Event ID |
95241 |
| Product Classification |
Protector, ostomy - Product Code EXE
|
| Product | eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal |
|---|
| Code Information |
UDI/DI 00768455108732, Lot number 109357C553 |
Recalling Firm/
Manufacturer |
T.G. Eakin Limited
15 Ballystockart Road
Comber Ireland
|
Manufacturer Reason
for Recall | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Eakin notified its sole consignee (a distributor) of the recall via email on 08/08/2024. The notice explained the issue and requested that any affected product be discarded. The consignee notified its customers on 08/14/2024 of the recall, requesting that the affected product be discarded.
For questions, please contact: In USA, Convatec Inc. on 1-800-422-8811.
In Canada, Convatec Canada Limited on 1-800-465-6302. |
|---|
| Quantity in Commerce | 35,400 cartons of 20 individually packaged seals |
|---|
| Distribution | US: KY |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
