Recall Z-1003-2017— J&J Solutions, Inc. DBA Corvida Medical

Name: FDA recall Z-1003-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-22

Class II · Terminated

Class II FDA medical device recall by J&J Solutions, Inc. DBA Corvida Medical, initiated 2016-11-22, terminated 2018-11-09. It names one FDA 510(k) clearance: K150486. Product: Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.. Reason: Product malfunction: Needle does not retract..

Recalling firm: J&J Solutions, Inc. DBA Corvida Medical
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Terminated: 2018-11-09
Firm location: Coralville, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K150486 — HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical·cleared 2015-07-24

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

Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.

Reason for recall

Product malfunction: Needle does not retract.

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