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U.S. Department of Health and Human Services

Class 1 Device Recall TorFlex Transseptal Guiding Sheath

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 Class 1 Recall
TorFlex Transseptal Guiding Sheath
see related information
Date Posted March 10, 2010
Recall Status1 Terminated on September 13, 2010
Recall Number Z-0816-2010
Recall Event ID 54526
Premarket Notification
510(K) Number
K013919 
Product Classification Introducer, Catheter - Product Code DYB
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.
Code Information Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1.
Recalling Firm/
Manufacturer
Baylis Medical Corp *
5959 Trans-Canada Hwy
Montreal
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Radiopaque soft tip may fracture.
FDA Determined
Cause 2
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BAYLIS MEDICAL CO., INC.
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