Medical Devices

Baylis Medical TorFlex Transseptal Guiding Sheath Kit

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.

Recalling Firm:
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.  

Public Contact:         
Baylis Medical Company
Phone: (800) 850-9801
Fax: (905) 602-5671 or by e-mail to info@baylismedical.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.

Additional Links:
AFFECTED PART/LOT NUMBER TABLE

Part Lot Number Expiry
TF8-32-63-90 TFFA070213 31-Dec-14
TF8-32-63-90 TFFA070912 30-Sep-13
TF8-32-81-135 TFFH070912 31-Aug-14
TF8-32-81-37 TFFD070912 31-Aug-14
TF8-32-81-45 TFFE070912 31-Aug-14
TF8-32-81-55 TFFF070912 31-Aug-14
TF8-32-81-90 TFFG070912 31-Jan-15
TF8-38-62-S TFFA201212 31-Dec-14
TF85-32-63-37 TFFC070912 30-Sep-13
TF85-32-63-45 TFFA221211 31-Jul-14
TF85-32-63-45 TFFA250512 31-Jan-15
TF85-32-63-45 TFFC051212 31-Jan-15
TF85-32-63-45 TFFC230812 30-Sep-14
TF85-32-63-55 TFFA230113 29-Feb-16
TF85-32-63-55 TFFA290812 30-Sep-13
TF85-32-63-55 TFFB070612 31-Jan-15
TF85-32-63-90 TFFB230812 30-Sep-13
TF85-32-63-90 TFFC260413 31-May-16
TF85-32-63-90 TFFC280213 28-Feb-15
TF85-32-63-90 TFFF070213 31-Mar-15
TF85-32-81-135 TFFC280912 31-Oct-14
TF85-32-81-37 TFFA280912 31-Oct-14
TF85-32-81-90 TFFB280912 31-Oct-14

Page Last Updated: 11/06/2013
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