Reported May 27, 2020 · Terminated
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135,…
Baylis Medical Company Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baylis Medical Company Inc. · 2645 Matheson Blvd E · Mississauga, N/A · N/A
Is this the product you have?
- TorFlex Transseptal Guiding Sheath
- Model numbers
TF8-32-63-45TF8-32-63-55TF8-32-63-90TF8-32-63-135TF85-32-63-37TF85-32-63-45TF85-32-63-55TF85-32-63-90TF85-32-63-135TF8-32-81-45TF8-32-81-55TF8-32-81-90TF85-32-81-37TF85-32-81-45TF85-32-81-55and TF85-32-81-90
- Lot codes and dates
- All lots of the following model numbers
TF85 32 63 90TFFA031116TF85 32 63 135TFFA231116TF8 32 63 90TFFL211016TF85 32 63 45TFFA261016TF85 32 63 55TFFB261016TF85 32 63 45TFFC031116TF8 32 63 45TFFH031116TF85 32 63 45TFFA261016TF85 32 63 45TFFD031116TF8 32 63 90TFFF031116
- All lots of the following model numbers
- Amount recalled
- Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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