Recall Z-0085-2014 ยท DYB Introducer, Catheter
Baylis Medical Corp *
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.
| Date | Nov 1, 2013 (initiated Sep 23, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 370 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., Apr 1, 2011 |