Z-2070-2020 Class II Terminated
FDA device recall Z-2070-2020 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 the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the pr… 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
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 Pattern
Product distributed throughout the 50 states and in Washington D.C.
Code Information
All lot numbers of the following kit model numbers: 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.