FDA-Device2013-11-13Class I
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
Baylis Medical Corp *
Hazard
The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
Sold states
Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.
Affected count
370 devices
Manufactured in
5959 TransCanada Highway, N/A, Montreal, N/A, Canada
Products
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2014Don't want to check this manually?
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