Home / Recalls / Baylis Medical Company Inc. / Z-2069-2020

Z-2069-2020 Class II Terminated

Recalled by Baylis Medical Company Inc. — Mississauga, N/A

Recall Details

Product Type: Devices
Report Date: May 27, 2020
Initiation Date: October 7, 2019
Termination Date: June 30, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).

Product Description

TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.

Reason for Recall

There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.

Distribution Pattern

Product distributed throughout the 50 states and in Washington D.C.

Code Information

All lots of the following model numbers: TF85 32 63 90, TFFA031116, TF85 32 63 135, TFFA231116, TF8 32 63 90, TFFL211016, TF85 32 63 45, TFFA261016, TF85 32 63 55, TFFB261016, TF85 32 63 45, TFFC031116, TF8 32 63 45, TFFH031116, TF85 32 63 45, TFFA261016, TF85 32 63 45, TFFD031116, TF8 32 63 90, TFFF031116