Recall Z-1003-2017 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
J&J Solutions, Inc. DBA Corvida Medical
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.
| Date | Nov 22, 2016 |
| Status | Terminated |
| Reason | Product malfunction: Needle does not retract. |
| Root cause | Under Investigation by 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 a |
| Quantity | 5520 units |
| Distribution | US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150486 | Halo J & J Solutions, Inc. D/B/A/ Corvida Medical, Jul 24, 2015 |