Z-0161-2016Class II

Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood...

Name: Z-0161-2016 Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood...
Creator: Nipro Medical Corporation
Published: 2015-08-13
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2015-08-13 / Terminated / root cause: labeling and UDI

FDA source

Nipro Medical Corporation began a recall of Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an... on 2015-08-13. FDA classified it as Class II and gives the reason as "Some 1 1/4" needles were packaged and labeled in the 1" blister package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0161-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-13
Posted: 2015-10-23
Terminated: 2017-10-13
Recalling firm: Nipro Medical Corporation
Product: Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
Product code: LLB System, Blood, Extracorporeal And Accessories
Reason for recall: Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Customers were issued a RMA 60001203 on August 18, 2015.
Quantity in commerce: 50,000 pieces
Distribution: Indiana
Product codes and lots: Lot # 15C03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-23

Product code LLB

K071145Class IINipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation / cleared 2007-09-07

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)