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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic(Covidien)Palindrome Precision Chronic Catheter Kit

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  Class 2 Device Recall Medtronic(Covidien)Palindrome Precision Chronic Catheter Kit see related information
Date Initiated by Firm October 14, 2015
Date Posted November 24, 2015
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-0333-2016
Recall Event ID 72416
510(K)Number K123196  
Product Classification Catheter, hemodialysis, implanted, coated - Product Code NYU
Product Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145061P

The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Code Information Lot Numbers: 1425000092
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Incorrectly packaged with a 90 degree bend at the distal tip
FDA Determined
Cause 2		 Packaging process control
Action The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 10 units
Distribution Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, 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 = NYU and Original Applicant = COVIDIEN
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