Z-2069-2020Class II

TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135...

Name: Z-2069-2020 TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135...
Creator: Baylis Medical Company Inc.
Published: 2019-10-07
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2019-10-07 / Terminated / root cause: packaging

FDA source

Baylis Medical Company Inc. began a recall of 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... on 2019-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2069-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2020-05-21
Terminated: 2021-06-30
Recalling firm: Baylis Medical Co., Inc.
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: packaging
FDA 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2070-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code DYB

K102948Class IITorflex Transseptal Guiding SheathBaylis Medical Co., Inc. / cleared 2011-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)