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U.S. Department of Health and Human Services

Class 2 Device Recall NiproSet SLIMLINE Blood Tubing Set

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  Class 2 Device Recall NiproSet SLIMLINE Blood Tubing Set see related information
Date Initiated by Firm March 30, 2015
Date Posted January 08, 2016
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-0624-2016
Recall Event ID 72701
510(K)Number K112628  
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
Product NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set

A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
Code Information Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.  
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		 Blood foaming was found during evaluation of the product.
FDA Determined
Cause 2		 Device Design
Action NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to JessicaO@nipromed.com / 305.599.7174x249.
Quantity in Commerce 1,484 pieces.
Distribution US Distribution to states of: TN and NJ.
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 = FJK and Original Applicant = NIPRO MEDICAL CORPORATION
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