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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 Styletsee related information
Date Initiated by FirmApril 23, 2015
Date PostedJuly 01, 2015
Recall Status1 Terminated 3 on July 26, 2017
Recall NumberZ-1901-2015
Recall Event ID 70985
510(K)NumberK062671 K112477 K123196 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductPalindrome 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
ActionMedtronic (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 Commerce72,363 US - 24,631 Internationally
DistributionWorldwide 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 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 = MSD
510(K)s with Product Code = MSD
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