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U.S. Department of Health and Human Services

Class 3 Device Recall Kendall Tyco/healthcare

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  Class 3 Device Recall Kendall Tyco/healthcare see related information
Date Initiated by Firm December 02, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0233-04
Recall Event ID 27842
510(K)Number K030209  
Product Classification Catheter, Hemodialysis, Non-Implanted - Product Code MPB
Product Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm
For hemodialysis, apheresis, and infusion.
Reference: 8888-135192
Code Information Lot Number: 140885
Recalling Firm/
Kendall Healthcare Products Co
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact David Olson
Manufacturer Reason
for Recall
Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm
FDA Determined
Cause 2
Action Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.
Quantity in Commerce 45 units
Distribution IL, MA, OH, TN, TX, VA
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 = MPB and Original Applicant = THE KENDALL COMPANY