TorFlex Transseptal Guiding Sheath — Class II medical device recall Z-2069-2020
Terminated recall by Baylis Medical Company Inc., reported 2020-05-27, distributed in WA. There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromi
| Recall number | Z-2069-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baylis Medical Company Inc., Mississauga, N/A, Canada |
| Recall initiated | 2019-10-07 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-06-30 |
| Distributed | WA |
| Quantity | 59,067 units |
| Reason classes | sterility, packaging |
| Model numbers | 135, TF8, TF8-32-63-135, TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85, TF85-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, TF85-32-81-90, TFFA031116, TFFA231116, TFFA261016, TFFB261016, TFFC031116, TFFD031116 and 3 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2069-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.