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U.S. Department of Health and Human Services

Class 2 Device Recall Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet

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  Class 2 Device Recall Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet see related information
Date Initiated by Firm April 23, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 on July 26, 2017
Recall Number Z-1901-2015
Recall Event ID 70985
510(K)Number K062671  K112477  K123196  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049CP
Code Information Item codes identified with an expiry date of February 2018 and earlier
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall		 Catheters may not meet antimicrobial specification
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am  6:30pm ET, at (800)-882-5878. For questions regarding this recall call 203-492-5000.
Quantity in Commerce 72,363 US - 24,631 Internationally
Distribution Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MSD and Original Applicant = COVIDIEN
510(K)s with Product Code = MSD and Original Applicant = KENDALL
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