Recall Z-1996-2014— RGI Medical Manufacturing, Inc.

Name: FDA recall Z-1996-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-28

Class II · Terminated

Class II FDA medical device recall by RGI Medical Manufacturing, Inc., initiated 2014-03-28, terminated 2016-09-29. It names one FDA 510(k) clearance: K001599. Product: Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.. Reason: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use..

Recalling firm: RGI Medical Manufacturing, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-28
Terminated: 2016-09-29
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K001599 — ACTI-FLEX IV ADMINISTRATION SETR-Group Intl.·cleared 2000-09-18

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

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

Reason for recall

Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

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