medical Class II Updated 2020-05-27

Baylis Medical Company Inc. recalls TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-6

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

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

Lot/Code Info: 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

View official government recall

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