FDA Device

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.

Hazard

Product malfunction: Needle does not retract.

What You Should Do

Remedy

Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.

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, Cor
Brand
J & J Solutions, Inc. DBA Corvida Medical
UPC
Lot 0610525, 2017-10-18

Units Affected

5520 units