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
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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 |
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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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