Medline Packs with Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Suture
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Simple Neck Dissection |
23FBH342 |
DYNJ47481F |
Pacemaker PK SHSC-LF |
23BBJ268 |
DYNJ46785C |
Composite Neck Dissection SHSC-LF |
23BBM531 |
DYNJ46776D |
Parotid |
23BBL719 |
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
Medline Industries, LP
Three Lakes Drive, Northfield, Illinois, United States, 60093
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