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Ethibond excel® , ethibond®, permahand®, prolene® sutures
Official notice
9 Jan 2025
Last checked
9 Jan 2025
An official Health Canada notice concerns Ethibond excel® , ethibond®, permahand®, prolene® sutures. An open seal defect was detected during internal rework activities. Investigation determined that the preliminary cause of issue was a machine failure, leading to the zipper tray to be incorrectly positioned in the copolymer pre-formed cavity and subsequent tray misalignment with the front seal area in the sealing process. This ultimately resulted in possibility of open seal condition and/or narrow seal defects in the subsequent units. Recall start date: December 30, 2024 Published 2025-01-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76812
Official notice
2025-01-09
The hazard
The hazard
An open seal defect was detected during internal rework activities. Investigation determined that the preliminary cause of issue was a machine failure, leading to the zipper tray to be incorrectly positioned in the copolymer pre-formed cavity and subsequent tray misalignment with the front seal area in the sealing process. This ultimately resulted in possibility of open seal condition and/or narrow seal defects in the subsequent units. Recall start date: December 30, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Ethicon, Ethibond Excel® Ethibond® Permahand® Prolene® Sutures.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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