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U.S. Department of Health and Human Services

Class 2 Device Recall NRG RF Transseptal Kit containing TorFlex" Transseptal Guiding Sheath

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  Class 2 Device Recall NRG RF Transseptal Kit containing TorFlex" Transseptal Guiding Sheath see related information
Date Initiated by Firm October 07, 2019
Date Posted May 21, 2020
Recall Status1 Terminated 3 on June 30, 2021
Recall Number Z-2070-2020
Recall Event ID 85353
510(K)Number K102948  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
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. 
Recalling Firm/
Manufacturer		 Baylis Medical Company Inc.
2645 Matheson Blvd E
Mississauga Canada
For Additional Information Contact Ellen Harfield
800-276-4416
Manufacturer 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.
FDA Determined
Cause 2		 Package design/selection
Action The firm sent Urgent Medical Device Recall Notification letters to customers via UPS and/or by email on 07-Oct-2019. The notifications were followed through by a tracking number to facilitate confirmation of package delivery. Customers were informed that all Torflex Transseptal Guiding Sheaths sold separately or as part of the NRG Transseptal kit are affected by this action. Customers were instructed to examine their stock, determine whether they had any of the affected lot numbers in stock, and if so, to quarantine affected product. Customers were requested to complete the acknowledgement form and return it to Baylis within 3 business days by email at torflexfieldaction@baylismedical.com or by faxing the completed form to 906-602-5671 Attn: Quality Department. Customers were informed that once the completed Acknowledgement form was received by Baylis, they would be contacted by a Baylis Medical Representative within 5 business days to manage the disposition of any identified quarantined product. Customers were instructed to address specific questions regarding the recall to Mrs. Ellen Harfield, Director of Quality at 1-800-276-4416.
Quantity in Commerce Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
Distribution Product distributed throughout the 50 states and in Washington D.C.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BAYLIS MEDICAL CO., INC.
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