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.
FDA Recall Z-1876-2018 · Posted None
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Recalling FirmNipro Medical Corporation
Recall StatusTerminated
Product CodeFJK
Date Initiated2017-12-19
Date Terminated2021-10-19
Product Quantity307,944 units.
Reason for Recall
There is a possibility of the heparin line is occluded.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Distribution to the states of : GA, NY, TN, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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