FDA recall Z-2070-2020

Product

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.

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-10-07

Report date

2020-05-27

Termination date

2021-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mississauga, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2020