Z-1876-2018Class II

Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch...

Name: Z-1876-2018 Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch...
Creator: Nipro Medical Corporation
Published: 2017-12-19
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

Nipro Medical Corporation began a recall of 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... on 2017-12-19. FDA classified it as Class II and gives the reason as "There is a possibility of the heparin line is occluded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1876-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-05-15
Terminated: 2021-10-19
Recalling firm: Nipro Medical Corporation
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.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: There is a possibility of the heparin line is occluded.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1876-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code FJK

K072024Class IINipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp. / cleared 2007-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)