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Class 1 Device Recall TorFlex Transseptal Guiding Sheath |
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Date Initiated by Firm |
February 08, 2010 |
Date Posted |
March 10, 2010 |
Recall Status1 |
Terminated 3 on September 13, 2010 |
Recall Number |
Z-0816-2010 |
Recall Event ID |
54526 |
510(K)Number |
K013919
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Product Classification |
Introducer, catheter - Product Code DYB
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Product |
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.
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Code Information |
Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1. |
Recalling Firm/ Manufacturer |
Baylis Medical Corp * 5959 Trans-Canada Hwy Montreal Canada
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Manufacturer Reason for Recall |
Radiopaque soft tip may fracture.
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FDA Determined Cause 2 |
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 in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = BAYLIS MEDICAL CO., INC.
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