Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a 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.
Recall
- Recall Number
- Z-0085-2014
- Event Number
- 66368
- Firm
- Baylis Medical Corp 5959 TransCanada Highway Montreal Canada
- FEI Number
- 3005241199
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- September 23, 2013
- Posted
- November 1, 2013
- Terminated
- March 31, 2015
Description
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a 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.
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.
Baylis Medical sent an Urgent Device Recall Notification letter dated September 23, 2013, via overnight courier to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form provided and fax to 905-602-5671 ATTN: Quality Department to arrange for a free of charge replacement of the affected product. The form requires consignees to return the affected product. For questions contact Quality Assurance at 800-276-4416.
Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.
370 devices