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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-0745-03
Recall Event ID 25817
Product Tandem-Cath Hemodialysis Cuffed Catheter with no side holes
10 Fr 19 cm Arterial Cuff/22cm Venous Cuff
Code #: 8888-219220
Code Information All lots
Recalling Firm/
Tyco Healthcare/Kendall
15 Hampshire Street
Mansfield MA 02048
For Additional Information Contact David A. Olson
Manufacturer Reason
for Recall
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
FDA Determined
Cause 2
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 215
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.