Recall MonitorHealth Products
ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® sutures
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: ETHIBOND EXCEL® , ETHIBOND®, PERMAHAND®, PROLENE® sutures
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| ETHIBOND® Extra Polyester Suture | 103H4B | X425H |
| PROLENE® Suture - Taper Point | 103E22 | 8706H |
| PERMAHAND® Non Absorbable Silk Suture | 10386S 103DBT | 623H K872H |
| ETHIBOND EXCEL® Polyester Suture | 103ELK | X872H |
Issue
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