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U.S. Department of Health and Human Services

Class 2 Device Recall ProTrack Microcatheter

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 Class 2 Device Recall ProTrack Microcathetersee related information
Date Initiated by FirmMarch 30, 2015
Date PostedApril 13, 2015
Recall Status1 Terminated 3 on November 17, 2016
Recall NumberZ-1442-2015
Recall Event ID 70896
510(K)NumberK014075 
Product Classification Wire, guide, catheter - Product Code DQX
ProductProTrack 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
For Additional Information ContactEllen Harfield
800-276-4416
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.
FDA Determined
Cause 2		Process control
ActionA 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 Commerce58 units
DistributionUS 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DQX
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