Baylis Medical Company Inc. Recall: TorFlex Transseptal Guiding Sheath ; Model numbers: TF
Baylis Medical Company Inc. Recall: TorFlex Transseptal Guiding Sheath ; Model numbers: TF is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Baylis Medical Company Inc.; Product: TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135,
| Recalling firm | Baylis Medical Company 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product distributed throughout the 50 states and in Washington D.C. |
| Recall initiated | 20191007 |
| Recall number | Z-2069-2020 |
| Category | device |
| State | N/A |
| Country | Canada |
$29/mo
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