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: 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.

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.