FDA recall Z-2069-2020

Product

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

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-2069-2020