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U.S. Department of Health and Human Services

Class 2 Device Recall Nipro

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  Class 2 Device Recall Nipro see related information
Date Initiated by Firm May 04, 2013
Date Posted June 19, 2014
Recall Status1 Terminated 3 on March 02, 2015
Recall Number Z-1834-2014
Recall Event ID 65274
510(K)Number K011297  
Product Classification Catheter,intravascular,therapeutic,short-term less than - Product Code FOZ
Product NIPRO Safe Touch Safety Scalp Vein Set
Code Information Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.
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		 There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
FDA Determined
Cause 2		 Component design/selection
Action Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621. Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.
Quantity in Commerce 176,000 pieces
Distribution Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
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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