CanadaTerumo Medical Corporation’s Glidesheath Slender® Introducer Sheath, model/catalogue number 60-1060, lot number 0001441871 is affected. A portion of the lot has an incorrect guidewire size causing the guidewire to not pass through the needle; Terumo has received 84 complaints, with no serious injuries reported and the issue detectable at time of use. Review your Glidesheath Slender inventory and immediately isolate lot number 0001441871, and contact the manufacturer if you require additional information.
What's being recalled
Companies: Terumo Medical Corporation, 950 Elkton Blvd., Elkton, Maryland, United States, 21921.
How to identify it
Affected products: Glidesheath Slender® Introducer Sheath; Lot or serial number: 0001441871; Model or catalogue number: 60-1060
The hazard
Through post-market surveillance, we have received complaints for the guidewire not being able to pass through the needle. Through our investigation it was determined that a portion of the lot had the incorrect guidewire size. Terumo has received 84 complaints for this issue and no serious injuries. The probability of medically reversible or transient adverse health consequences is not likely. The situation is detectable at the time of use. There is no risk to patients who have used this lot. 1. Review your Glidesheath Slender inventory and immediately isolate lot number 0001441871.
What to do
Contact the manufacturer if you require additional information
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States