Recall Z-0675-2016— Rymed Technologies, LLC

Name: FDA recall Z-0675-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-05

Class II · Terminated

Class II FDA medical device recall by Rymed Technologies, LLC, initiated 2016-01-05, terminated 2016-10-19. It names one FDA 510(k) clearance: K991653. Product: InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.. Reason: Potential for the female luer component of the InVision-Plus IV connector to crack during use..

Recalling firm: Rymed Technologies, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Terminated: 2016-10-19
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K991653 — INVISION-PLUS INJECTION PORT CONNECTOR SYSTEMRymed Technologies, Inc.·cleared 1999-06-24

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

InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

Reason for recall

Potential for the female luer component of the InVision-Plus IV connector to crack during use.

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