FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1003-2017
- Recalling firm
- J&J Solutions, Inc. DBA Corvida Medical
- 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.
- Status
- Terminated
- Initiated
- 2016-11-22
- Posted
- not on file
- Terminated
- 2018-11-09
- 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 at (800) 651-6832.
- Quantity
- 5520 units
- Distribution
- US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot 0610525, 2017-10-18
- 510(k) numbers
- ["K150486"]
- PMA numbers
- not on file
- Product code
- ONB
- Firm FEI
- 3012235045
- Firm city
- Coralville
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28