Recall Z-0599-2016— Nipro Medical Corporation

Name: FDA recall Z-0599-2016
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class III · Terminated

Class III FDA medical device recall by Nipro Medical Corporation, initiated 2014-04-01, terminated 2016-12-14. It names one FDA 510(k) clearance: K032777. Product: NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.. Reason: Device has the potential to have torn wings..

Recalling firm: Nipro Medical Corporation
Classification: Class III
Status: Terminated
Initiated: 2014-04-01
Terminated: 2016-12-14
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLENipro Medical Corp.·cleared 2003-11-14

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 SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

Reason for recall

Device has the potential to have torn wings.

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