Medline Packs with Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Suture
Brand(s)
Last updated
Summary
Product
Medline Packs with Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Suture
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Simple Neck Dissection | 23FBH342 | DYNJ47481F |
| Pacemaker PK SHSC-LF | 23BBJ268 23BBK356 23ABC131 22LBR066 23CBS913 | DYNJ46785C |
| Composite Neck Dissection SHSC-LF | 23BBM531 | DYNJ46776D |
| Parotid | 23BBL719 23BBE584 23CBR156 | DYNJ905111A |
Issue
Specific lots of the Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of ethylene oxide (EO) sterilization cycles. The affected devices were distributed as part of Medline packs between Sep 2022 and January 2024. The extra gamma levels or additional ethylene oxide (EO) cycle have the potential to decrease the strength of these sutures over time.
Recall start date: January 19, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Medline Industries, LP
Three Lakes Drive, Northfield, Illinois, United States, 60093
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75025
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