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.
FDA Recall Z-1003-2017 · Posted None
Recalling FirmJ&J Solutions, Inc. DBA Corvida Medical
Recall StatusTerminated
Product CodeONB
Date Initiated2016-11-22
Date Terminated2018-11-09
Product Quantity5520 units
Reason for Recall
Product malfunction: Needle does not retract.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.