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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLB
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