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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall

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  Class 2 Device Recall Kendall see related information
Date Initiated by Firm March 20, 2003
Date Posted April 18, 2003
Recall Status1 Terminated 3 on May 12, 2021
Recall Number Z-0744-03
Recall Event ID 25817
510(K)Number K002902  
Product Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff
Code #: 8888-228316
Code Information All lots
Recalling Firm/
Manufacturer		 Tyco Healthcare/Kendall
15 Hampshire Street
Mansfield MA 02048
For Additional Information Contact David A. Olson
508-261-8530
Manufacturer Reason
for Recall		 Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
FDA Determined
Cause 2		 Other
Action The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.
Quantity in Commerce 160
Distribution Nationwide International: Canada, Chile, Singapore. Belgium
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 = and Original Applicant = THE KENDALL COMPANY
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