Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ProTrack Microcatheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ProTrack Microcathetersee related information
Date Initiated by FirmOctober 28, 2015
Date PostedDecember 01, 2015
Recall Status1 Terminated 3 on November 17, 2016
Recall NumberZ-0356-2016
Recall Event ID 72539
510(K)NumberK014075 
Product Classification Wire, guide, catheter - Product Code DQX
ProductProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Code Information CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215
Recalling Firm/
Manufacturer		 Baylis Medical Corp *
5959 TransCanada Highway
Montreal Canada
For Additional Information ContactCustomer Service
800-850-9801
Manufacturer Reason
for Recall		Microcatheter may have circumferential defects (cracks) along its shaft.
FDA Determined
Cause 2		Process control
ActionRecall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm.
Quantity in Commerce433 units
DistributionNationwide Distribution.
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
-
-