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Class 2 Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film |
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Date Initiated by Firm |
December 19, 2017 |
Create Date |
May 15, 2018 |
Recall Status1 |
Terminated 3 on October 19, 2021 |
Recall Number |
Z-1876-2018 |
Recall Event ID |
79834 |
510(K)Number |
K072024
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Product Classification |
Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
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Product |
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case.
The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge. |
Code Information |
Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9. |
Recalling Firm/ Manufacturer |
Nipro Medical Corporation 3150 NW 107th Ave Doral FL 33172-2135
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For Additional Information Contact |
Jessica Oswald-McLeod 305-599-7174
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Manufacturer Reason for Recall |
There is a possibility of the heparin line is occluded.
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FDA Determined Cause 2 |
Process control |
Action |
Customers were notified on approximately December 19, 2017, via letter. Instructions included to place affected lots on hold and to advise Nipro if any affected product has been further distributed. If affected product has been further distributed, Nipro advised the customer to notify those customers and have the product returned immediately. Additionally Nipro requested that they complete and return the response form to arrange for product return. For further questions, please call (305) 599-7174. |
Quantity in Commerce |
307,944 units. |
Distribution |
US Distribution to the states of : GA, NY, TN, TX. |
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 = FJK and Original Applicant = NIPRO MEDICAL CORP.
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