Recall Z-0161-2016— Nipro Medical Corporation

Name: FDA recall Z-0161-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-13

Class II · Terminated

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2015-08-13, terminated 2017-10-13. It names one FDA 510(k) clearance: K071145. 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.. Reason: Some 1 1/4" needles were packaged and labeled in the 1" blister package..

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-08-13
Terminated: 2017-10-13
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K071145 — NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLENipro Medical Corporation·cleared 2007-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Some 1 1/4" needles were packaged and labeled in the 1" blister package.

Data sourced from openFDA. This site is unofficial and independent of the FDA.