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U.S. Department of Health and Human Services

Class 2 Device Recall Nipro Safetouch, Baxter Safety AV, EXEL Secure Touch

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  Class 2 Device Recall Nipro Safetouch, Baxter Safety AV, EXEL Secure Touch see related information
Date Initiated by Firm November 08, 2002
Date Posted May 21, 2003
Recall Status1 Terminated 3 on April 15, 2008
Recall Number Z-0408-03
Recall Event ID 25052
510(K)Number K002813  
Product Classification Needle, Fistula - Product Code FIE
Product The following brand name labeled products are under recall (all
catalog numbers and all lot numbers under recall):
NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula
Set and EXEL Secure Touch Safety AV Fistula Needle Set.
Code Information All lot numbers in current distribution are under recall.
Recalling Firm/
Manufacturer		 Nipro Corp
3150 NW 107th Avenue
Brokers Box 97
Miami FL 33172
Manufacturer Reason
for Recall		 Air or fluid leakage at the hub/needle junction.
FDA Determined
Cause 2		 Other
Action The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
Quantity in Commerce 6,984,000
Distribution Nationwide and Canada
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 = FIE and Original Applicant = NIPRO MEDICAL CORP.
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