# FDA recall Z-2069-2020

> **Baylis Medical Company Inc.** · Class II · device recall initiated 2019-10-07.

## 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.

## Distribution

Product distributed throughout the 50 states and in Washington D.C.

## Key facts

- **Recall number:** Z-2069-2020
- **Recalling firm:** Baylis Medical Company Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2020-05-27
- **Termination date:** 2021-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mississauga, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2020

## Citation

> AI Analytics. FDA recall Z-2069-2020. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2069-2020. Source: US FDA. Licensed CC0.

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