FDA-Device2017-01-18Class II

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.

J&J Solutions, Inc. DBA Corvida Medical
Hazard

Product malfunction: Needle does not retract.

Sold states
US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
Affected count
5520 units
Manufactured in
2261 Crosspark Rd Ste 127, Coralville, IA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2017

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