Recall Z-0676-2016— Rymed Technologies, LLC

Name: FDA recall Z-0676-2016
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: K093489. Product: InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. 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

K093489 — IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGYRymed Technologies, Inc.·cleared 2010-07-29

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 CS Needleless IV Connector, Catalog Number RYM-7001. 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.