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U.S. Department of Health and Human Services

Class 3 Device Recall ProLong

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  Class 3 Device Recall ProLong see related information
Date Initiated by Firm May 09, 2001
Date Posted July 15, 2003
Recall Status1 Terminated 3 on July 15, 2003
Recall Number Z-1003-03
Recall Event ID 26498
510(K)Number K001129  
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100
Code Information All manufacturing codes were recalled.  Model numbers: PL-50, PL-100
Recalling Firm/
Manufacturer
Life-Tech International, Inc
4235 Greenbriar Dr
Stafford TX 77477-3995
Manufacturer Reason
for Recall
Catheter does not fit through the needle resulting in delay of medical procedure
FDA Determined
Cause 2
Other
Action The firm initiated the recall via letter to all consignees on May 9, 2001.
Distribution CA, MN, TX, FL, UT,
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 = CAZ and Original Applicant = LIFE-TECH INTL., INC.
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