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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 October 08, 2004
Date Posted November 02, 2004
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0122-05
Recall Event ID 30196
510(K)Number k012736  
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product MAGELLAN 22x1'' TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851210
Code Information Lot numbers in the range of 406100 through 424600 (inclusive)
Recalling Firm/
Kendall Healthcare Products Co
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact James Welsh
Manufacturer Reason
for Recall
Needle cannula may separate from the hub during use
FDA Determined
Cause 2
Action Recall letters requesting product return were mailed to all customers on October 8, 2004
Distribution Nationwide
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 = FMI and Original Applicant = TYCO HEALTHCARE