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Class 2 Device Recall ProTrack Microcatheter |
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Date Initiated by Firm |
March 30, 2015 |
Date Posted |
April 13, 2015 |
Recall Status1 |
Terminated 3 on November 17, 2016 |
Recall Number |
Z-1442-2015 |
Recall Event ID |
70896 |
510(K)Number |
K014075
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Product Classification |
Wire, guide, catheter - Product Code DQX
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Product |
ProTrack Microcatheter;
Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. |
Code Information |
Lots CIFA180814 and CIFA080914 |
Recalling Firm/ Manufacturer |
Baylis Medical Corp * 5959 TransCanada Highway Montreal Canada
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For Additional Information Contact |
Ellen Harfield 800-276-4416
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Manufacturer Reason for Recall |
Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
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FDA Determined Cause 2 |
Process control |
Action |
A recall notification, marked "URGENT" will be sent by Baylis Medical via overnight courier to all customers affected by the recall with a fax-back form. The form is to be faxed back to Baylis Medical confirming receipt of the recall notice. As per instructions on the fax-back form, affected devices are requested to be returned. Baylis Medical will replace the returned affacted catheters with a new catheter. |
Quantity in Commerce |
58 units |
Distribution |
US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR |
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 = DQX and Original Applicant = BAYLIS MEDICAL CO., INC.
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