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U.S. Department of Health and Human Services

Class 3 Device Recall NIPRO SafeTouch II Safety AVF Needle

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  Class 3 Device Recall NIPRO SafeTouch II Safety AVF Needle see related information
Date Initiated by Firm April 01, 2014
Create Date January 06, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-0599-2016
Recall Event ID 72707
510(K)Number K032777  
Product Classification AV fistula needle - Product Code FOZ
Product NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
Code Information Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.
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		 Device has the potential to have torn wings.
FDA Determined
Cause 2		 Process control
Action The only one Distributor was notified (2014) by e-mail by the firm of the quality deficiency before the product arrived at their facility. It was immediately returned to Nipro Medical when it arrived.
Quantity in Commerce 160,000 pieces.
Distribution US distribution including TN.
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 = FOZ and Original Applicant = NIPRO MEDICAL CORP.
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