Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Recall
- Recall Number
- Z-0286-2024
- Event Number
- 93174
- Firm
- Cordis US Corp
- FEI Number
- 1016427
- Product Code
- DQO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 26, 2023
- Posted
- November 9, 2023
- Address
- 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802
Description
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Non-sterile product labeled as sterile was distributed.
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: [email protected] 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: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
US Distribution to: OK
30 devices