Health product recall

Medtronic Nonabsorbable Sutures

Brand(s)
Last updated

Summary

Product
Medtronic Nonabsorbable Sutures
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Ti-Cron Reverse Cutting 1/2 Circle Contact the manufacturer 8886305953
Monosof Nonabsorbable Monofilament Nylon Surgical Suture Contact the manufacturer N2781K SN1647
Ti-Cron Taper Point 1/2 Circle Contact the manufacturer 8886311179 8886301751 8886309051
Surgipro Nonabsorbable Monofilament Polypropylene Surgical Suture Contact the manufacturer CP825 CP535 VP543
Novafil Monofilament Polybutester Nonabsorbable Sutures Contact the manufacturer SPB1623G 8886442243 8886442451 SPB1233G SPB5633G 8886445251 SPB5142G
Ti-Cron Taper Cardiopoint, 300 Series Steel 3/8 Circle Contact the manufacturer 8886328031
Sofsilk Nonabsorbable Braided Silk Surgical Suture Contact the manufacturer CS490 GS835 S316 SS5684 SS683G S1173 S607 VS871-2 S245 S246 S2782K S244 S318 S183 S185 S605 S608 S184 VS872-2
Ti-Cron Penetrating Point 1/2 Circle Contact the manufacturer 8886311961 8886316041
Surgipro Ii Surgical Suture Contact the manufacturer VP541X VP735X VP900X VP745X VP902X
Ti-Cron Taper Cardiopoint, 300 Series Steel 1/2 Circle Contact the manufacturer 888632264

Issue

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier breach include infection or vision loss for ophthalmic procedures in cases where there is direct patient contact. Through 01-November-2022, Medtronic has received no complaints of packaging integrity defects or reports of serious patient injury related to this issue. There are no additional patient management recommendations for patients where potentially affected non-absorbable sutures in the scope of this recall were used during a procedure. These patients should continue to be monitored in accordance with the registered medical facility's standard care protocols with consideration to the specific use.

Recall start date: December 1, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Covidien Llc

15 Hampshire Street, Mansfield, Massachusetts, United States, 02048

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-72355