FDA Class I Recall Alert: Cordis INFINITI Angiographic Catheter
Recalled Product Information:
- Product Names: Cordis INFINITI Angiographic Catheter
- Product Codes: DQO
- Lot Number: 18223410
- Distribution Dates: August 21, 2023, to September 25, 2023
- Devices Recalled in the U.S.: 30 (3 X 10-pack boxes)
- Date Initiated by Firm: September 26, 2023
Device Use: The Cordis INFINITI Angiographic Catheter is a medical device designed to deliver contrast dye to specific locations within blood vessels. This aids medical professionals, particularly interventional radiologists or cardiologists, in visualizing blood vessels during procedures such as angiographies. The catheter is inserted into the body through the skin and can be utilized in multiple locations simultaneously.
Reason for Recall: Cordis US Corp has initiated a Class I recall of the INFINITI Angiographic Catheter due to a critical issue. Some products from Lot 18223410 were shipped to end-users without undergoing necessary sterilization procedures. The catheter is intended to be shipped sterile from the manufacturer to a third-party distributor, who then forwards the product to end-users, including hospitals.
Regrettably, Lot 18223410 was distributed without proper sterilization, with only 3 boxes (30 units out of 500) being returned to the manufacturer in Mexico. These 30 units were identified as being shipped to a single facility. Cordis US Corp promptly notified the sole consignee of the issue on September 26, 2023, and issued an Urgent Medical Device Recall Notice on September 28, 2023, urging the return of all affected products.
The use of unsterilized angiographic catheters poses a severe risk of acquired infections, sepsis, and, in extreme cases, death. Fortunately, there have been no reports of death or injury associated with this specific issue.
Who May be Affected:
- Medical professionals, especially interventional radiologists or cardiologists, who use the Cordis INFINITI Angiographic Catheter during procedures like angiographies.
- Individuals undergoing procedures like angiographies.
Recommended Actions:
- Cordis US Corp sent an Urgent Medical Device Recall Notice to the sole consignee on September 28, 2023.
- Customers are urged to check their inventory immediately to confirm the absence of units from the affected lots.
- Identify and set aside any units from the identified lots to prevent inadvertent use.
- Review, complete, sign, and return the Acknowledgement Form directly to Cordis via email at GMB-CordisFieldAction@cordis.com.
- Return any affected products promptly.
- Share the recall letter with relevant personnel within their facility and other facilities that may have received affected units.
Contact Information: Customers in the U.S. with questions regarding this recall should contact Cordis QA at GMB-CordisFieldAction@cordis.com or call Cordis Customer Support at 1-800-327-7714 (Option 2), Monday through Friday from 8:00 AM to 8:00 PM EDT.
Additional Resources:
How to Report a Problem: Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems related to these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Reports can be submitted online, via regular mail, or FAX, using the information available on the FDA’s official MedWatch website.
This Class I recall underscores the critical importance of immediate attention and action. Cordis US Corp is committed to addressing this issue promptly to ensure the safety and well-being of patients and healthcare professionals.
