Z-1003-2017Class II

Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as...

Name: Z-1003-2017 Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as...
Creator: J&J Solutions, Inc. DBA Corvida Medical
Published: 2016-11-22
License: https://open.fda.gov/license/

Cormed / initiated 2016-11-22 / Terminated

FDA source

J&J Solutions, Inc. DBA Corvida Medical began a recall of 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... on 2016-11-22. FDA classified it as Class II and gives the reason as "Product malfunction: Needle does not retract". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1003-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-01-11
Terminated: 2018-11-09
Recalling firm: Cormed
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.
Product code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Reason for recall: Product malfunction: Needle does not retract.
FDA 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 at (800) 651-6832.
Quantity in commerce: 5520 units
Distribution: US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
Product codes and lots: Lot 0610525, 2017-10-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1003-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code ONB

K150486Class IIHaloJ & J Solutions, Inc. D/B/A/ Corvida Medical / cleared 2015-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)