Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2069-2020·Announced 2020-05-27

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Baylis Medical Company Inc.
Category: Medical Device — Cardiac Catheter
Hazard: infection
packaging-defect
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 →

Same manufacturer · Baylis Medical Company Inc.

See all →

High
Baylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect
FDA (Devices) · 2020-05-27
Moderate
Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief
FDA (Devices) · 2013-03-06

Same hazard · infection