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U.S. Department of Health and Human Services

Class 3 Device Recall PALINDROME EMERALD Kit Cuffed Dual Lumen Catheter

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  Class 3 Device Recall PALINDROME EMERALD Kit Cuffed Dual Lumen Catheter see related information
Date Initiated by Firm September 19, 2008
Date Posted December 04, 2008
Recall Status1 Terminated 3 on December 04, 2008
Recall Number Z-0411-2009
Recall Event ID 50081
510(K)Number K060509  K051584  
Product Classification catheter, hemodialysis, implanted, coated - Product Code NYU
Product PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
Code Information Product code/REF Number 8888145070; Lot No. 809406 and 818002.
Recalling Firm/
Manufacturer		 Covidien
5439 State Route 40
Argyle NY 12809-3830
For Additional Information Contact James Welsh
508-261-8532
Manufacturer Reason
for Recall		 Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact jim.welsh@covidien.com or 508-216-8532.
Quantity in Commerce 20 units
Distribution Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.
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 = KENDALL
510(K)s with Product Code = NYU and Original Applicant = TYCO HEALTHCARE GROUP
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