FDA Medical Device Recalls (openFDA)
Cordis US Corp: Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
- Recall number
- Z-0286-2024
- Recalling firm
- Cordis US Corp
- Product
- Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
- Status
- Open, Classified
- Initiated
- 2023-09-26
- Posted
- 2023-11-09
- Terminated
- not on file
- Reason
- Non-sterile product labeled as sterile was distributed.
- Root cause
- Process control
- Action
- The account representative for the consignee notified the consignee by phone on September 26, 2023, providing details of the issue and instructed them to quarantine the impacted lot. Cordis then issued an "Urgent MEDICAL DEVICE RECALL" notice to its sole consignee by letter on 09/28/2023. The notice explained the issue, potential risk, and requested the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the Acknowledgement Form directly to Cordis by email to: GMB-CordisFieldAction@cordis.com 4) Return any affected product. Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Support at 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
- Quantity
- 30 devices
- Distribution
- US Distribution to: OK
- Lot, serial or model codes
- UDI/DI 10705032025935, Lot Number 18223410
- 510(k) numbers
- ["K970854"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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