Baylis Medical Company Inc.: Medical Device Recall in 2020 - (Recall #: Z-2070-2020)

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:

NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: May 27, 2020

Recall Number: Z-2070-2020

Event ID: 85353

Reason for Recall:

There is a remote potential for the sterile packaging 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 lot numbers of the following kit model numbers: NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N, and NTK-711-8555N.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated