Recall Z-2086-2019— Teleflex Medical

Name: FDA recall Z-2086-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-01

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2019-07-01, terminated 2021-11-04. It names one FDA 510(k) clearance: K000070. Product: Rusch EasyCath Kit. Reason: Potential for product not to be sterile..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2019-07-01
Terminated: 2021-11-04
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K000070 — FLOCATHRusch Intl.·cleared 2000-02-18

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

Rusch EasyCath Kit

Reason for recall

Potential for product not to be sterile.

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