Baylis Medical Company Inc.: Medical Device Recall in 2020 - (Recall #: Z-2069-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: May 27, 2020

Recall Number: Z-2069-2020

Event ID: 85353

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.

Status: Terminated

Product Quantity: Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated