Recall Z-2069-2020 ยท DYB Introducer, Catheter
Baylis Medical Company Inc.
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.
| Date | May 21, 2020 (initiated Oct 7, 2019) |
| Status | Terminated |
| Reason | 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 | 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 fo |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., Apr 1, 2011 |