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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/
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 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.
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