Z-0624-2016Class II

NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A...

Name: Z-0624-2016 NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A...
Creator: Nipro Medical Corporation
Published: 2015-03-30
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2015-03-30 / Terminated / root cause: design

FDA source

Nipro Medical Corporation began a recall of NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal... on 2015-03-30. FDA classified it as Class II and gives the reason as "Blood foaming was found during evaluation of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0624-2016
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Posted: 2016-01-08
Terminated: 2016-02-04
Recalling firm: Nipro Medical Corporation
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.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Blood foaming was found during evaluation of the product.
Root cause tag: design
FDA root cause: 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 [email protected] / 305.599.7174x249.
Quantity in commerce: 1,484 pieces.
Distribution: US Distribution to states of: TN and NJ.
Product codes and lots: Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0624-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-08

Product code FJK

K112628Class IINipro Blood Tubing Set with Transducer Protector and Priming SetNipro Medical Corporation / cleared 2012-09-28

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)