Z-2069-2020 Class II Terminated
FDA device recall Z-2069-2020 was initiated by Baylis Medical Company Inc. on October 7, 2019 and is designated Class II. 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 an… The recall status is terminated (terminated June 30, 2021). Affected quantity: Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits)..
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- October 7, 2019
- Termination Date
- June 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
Product Description
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 Pattern
Product distributed throughout the 50 states and in Washington D.C.
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