Recall Z-1834-2014— Nipro Medical Corporation

Name: FDA recall Z-1834-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-04

Class II · Terminated

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2013-05-04, terminated 2015-03-02. It names one FDA 510(k) clearance: K011297. Product: NIPRO Safe Touch Safety Scalp Vein Set. Reason: There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids..

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-05-04
Terminated: 2015-03-02
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K011297 — NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SETNipro Medical Corp.·cleared 2001-06-20

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 Safety Scalp Vein Set

Reason for recall

There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.

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