No image published for this recall

Medline packs with sofsilk™ braided silk sutures and ti-cron™ coated braided polyester suture

Official notice

7 Feb 2024

Last checked

7 Feb 2024

High riskHealth Canada

An official Health Canada notice concerns Medline packs with sofsilk™ braided silk sutures and ti-cron™ coated braided polyester suture. 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 Published 2024-02-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75025

Official notice

2024-02-07

Watch this recall in the app

The hazard

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

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

75025

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Affected products

Product 1

Affected products - Simple Neck Dissection, Lot or serial number - 23FBH342, Model or catalog number - DYNJ47481F

Product 2

Affected products - Pacemaker PK SHSC-LF, Lot or serial number - 23BBJ268 23BBK356 23ABC131 22LBR066 23CBS913, Model or catalog number - DYNJ46785C

Product 3

Affected products - Composite Neck Dissection SHSC-LF, Lot or serial number - 23BBM531, Model or catalog number - DYNJ46776D

Product 4

Affected products - Parotid, Lot or serial number - 23BBL719 23BBE584 23CBR156, Model or catalog number - DYNJ905111A

Risk / hazard

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Medline Lp, Medline Packs With Sofsilk™ Braided Silk Sutures And Ti-cron™ Coated Braided Polyester Suture

Manufacturer

Not provided

Phone

Not provided

Brand: Medline Lp, Medline Packs With Sofsilk™ Braided Silk Sutures And Ti-cron™ Coated Braided Polyester Suture.

Source & status

Source

Health Canada

Tier

official

Recall details

Recall number

75025

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice

Something wrong on this page?

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

Yes, email me the weekly recall digest. I can unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 7 Feb 2024. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.