Recall Z-0816-2010 ยท DYB Introducer, Catheter
Baylis Medical Corp *
Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.
| Date | Mar 10, 2010 (initiated Feb 8, 2010) |
| Status | Terminated |
| Reason | Radiopaque soft tip may fracture. |
| Root cause | Component design/selection |
| Action | Baylis Medical Issued an "Urgent Medical Device Correction" letter via overnight courier beginning February 8, 2010. Consignees were instructed to segregate and return all affected product to the firm. For further information, contact Baylis Medical Regulatory Scientific Affairs at 1-905-602-4875 Extension 252. |
| Quantity | 1,085 units (508 in US, 577 Foreign) |
| Distribution | Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., Feb 22, 2002 |