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U.S. Department of Health and Human Services

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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 Class 2 Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a filmsee related information
Date Initiated by FirmDecember 19, 2017
Create DateMay 15, 2018
Recall Status1 Terminated 3 on October 19, 2021
Recall NumberZ-1876-2018
Recall Event ID 79834
510(K)NumberK072024 
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
ProductNipro 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
For Additional Information ContactJessica Oswald-McLeod
305-599-7174
Manufacturer Reason
for Recall		There is a possibility of the heparin line is occluded.
FDA Determined
Cause 2		Process control
ActionCustomers 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 Commerce307,944 units.
DistributionUS Distribution to the states of : GA, NY, TN, TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FJK
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