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U.S. Department of Health and Human Services

Class 2 Device Recall Nipro Safe Touch TULIP Safety Fistula Needle

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  Class 2 Device Recall Nipro Safe Touch TULIP Safety Fistula Needle see related information
Date Initiated by Firm August 13, 2015
Date Posted October 23, 2015
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-0161-2016
Recall Event ID 72365
510(K)Number K071145  
Product Classification System, blood, extracorporeal and accessories - Product Code LLB
Product Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
Code Information Lot # 15C03
Recalling Firm/
Manufacturer		 Nipro Medical Corporation
3150 Nw 107th Ave
Miami FL 33172
For Additional Information Contact Jessica Oswald -McLeod
305-599-7174
Manufacturer Reason
for Recall		 Some 1 1/4" needles were packaged and labeled in the 1" blister package.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Customers were issued a RMA 60001203 on August 18, 2015.
Quantity in Commerce 50,000 pieces
Distribution Indiana
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 = LLB and Original Applicant = NIPRO MEDICAL CORPORATION
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