Reported Nov 13, 2013 · Terminated
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex…
Baylis Medical Corp. *
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Corp * · 5959 TransCanada Highway · Montreal, N/A · N/A
Is this the product you have?
- Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile
- Product UsageThe TorFlex Transseptal Guiding Sheath kit (K102948) is a single use
- device consisting of three componentsa sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations
- Lot codes and dates
33 of 33 products
Products covered by this recall Model / number Product as published TF8-32-63-135Lot TFFB070912 TF8-32-63-37Lot TFFA310812 — Part. No. TF8-32-63-37, Lot TFFB290113 TF8-32-63-45Lot TFFA290113 TF8-32-63-45Lot TFFB310812 TF8-32-63-45Lot TFFC221211 TF8-32-63-55Lot TFFA051212 TF8-32-63-55Lot TFFA230812 TF8-32-63-55Lot TFFB221211 TF8-32-63-55Lot TFFB230113 TF8-32-63-90Lot TFFA070213 TF8-32-63-90Lot TFFA070912 TF8-32-81-135Lot TFFH070912 TF8-32-81-37Lot TFFD070912 TF8-32-81-45Lot TFFE070912 TF8-32-81-55Lot TFFF070912 TF8-32-81-90Lot TFFG070912 TF8-38-62-SLot TFFA201212 TF85-32-63-37Lot TFFC070912 TF85-32-63-45Lot TFFA221211 - Amount recalled
- 370 devices
Where it was sold
Why it was recalled
Stop using this product now
The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
Using this product could cause serious injury, illness or death — stop using it now.
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