Baylis Medical Recalls TorFlex Transseptal Guiding Sheaths Due to Packaging Defects
Baylis Medical is recalling TorFlex Transseptal Guiding Sheaths because sterile packaging may be compromised during shipping, posing a remote risk of infection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly describes the risk as 'remote' and does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Baylis Medical Company Inc. is recalling specific lots of TorFlex Transseptal Guiding Sheaths. The recall involves 59,067 units, including individual units and those sold in NRG RF Transseptal Kits. The affected model numbers include 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.
The recall is due to a remote potential for the sterile packaging to be compromised during shipping and handling. If a packaging defect is not identified and the product is used in a patient, there is a remote risk of infection. The product was distributed throughout the 50 states and in Washington D.C.
Healthcare providers and facilities should stop using the affected lots and contact Baylis Medical for instructions on returning the product. Patients who have had the device implanted should contact their healthcare provider if they have concerns.
The recalled product
- 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 TF8
- Manufacturer
- Baylis Medical Company Inc.
- Affected units
- 59,067
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- All lots of the following model numbers: TF85 32 63 90
- TFFA031116
- TF85 32 63 135
- TFFA231116
- TF8 32 63 90
- TFFL211016
- TF85 32 63 45
- TFFA261016
- TF85 32 63 55
- TFFB261016
- TFFC031116
- TF8 32 63 45
- TFFH031116
- TFFD031116
- TFFF031116
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Baylis Medical Company Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Baylis Medical Company Inc.
See all →- HighBaylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect
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