FDA Medical Device Recalls (openFDA)
Baylis Medical Company Inc.: 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.
- Recall number
- Z-2070-2020
- Recalling firm
- Baylis Medical Company Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-10-07
- Posted
- 2020-05-21
- Terminated
- 2021-06-30
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K102948"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3000157372
- Firm city
- Mississauga
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28