Recall Class: Class I
Date Recall Initiated: September 23, 2013
Product(s): TorFlex Transseptal Guiding Sheath Kit
This recall covers 1,035 kits manufactured between 12/22/2011 and 07/24/2013. See list of affected lot numbers below.
Use: The TorFlex Transseptal Guiding Sheath Kit is a single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The components of the device include a sheath, a dilator and a J-tipped guidewire.
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Canada QC H4T 1A1
Reason for Recall: The sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream.
Baylis Medical Company
Phone: (800) 850-9801
Fax: (905) 602-5671 or by e-mail to email@example.com
FDA District: Dallas
FDA Comments: On Sept. 23, 2013 Baylis Medical Company sent an “URGENT DEVICE RECALL” letter to their customers. Customers were instructed to examine their inventory and quarantine affected TorFlex Transseptal Guiding Sheath lots. Customers are then asked to sign and return a Medical Device Correction Acknowledgment Form directly to Baylis to their Fax number (905) 602-5671. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
AFFECTED PART/LOT NUMBER TABLE
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Medical & Radiation Emitting Device Recalls Database