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-
FDA device recall Z-2069-2020 · posted 2020-05-21 · Terminated
Recall details
- Recalling firm
- Baylis Medical Company Inc.
- 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.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 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.
- Date initiated
- 2019-10-07
- Date posted
- 2020-05-21
- Date terminated
- 2021-06-30
- Location
- Mississauga, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K102948) | Baylis Medical Co., Inc. | 2011-04-01 |