Alcon Custom-Pak Constellation (Alcon) – Tubing Breakage (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

Recommended Action

Per FDA guidance

Alcon issued a letter dated October 16, 2024 "COMMUNICATION OF MEDICAL DEVICE CORRECTION FROM CARDINAL HEALTH" (ALCON CUSTOM PAK COMPONENT SUPPLIER) regarding Alcon Custom Pak surgical kits which contain Cardinal Health Salem Sump PVC Tubes - Double Lumen Nasogastric (NG) Tube. Alcon is instructing its customers to: (1) Read the attached Cardinal Health Medical Device Correction notice. Cardinal Health recommends customers review the eIFU and updated product labels. (2) Complete the attached Alcon Customer Response Form. (3) Return the Alcon Customer Response Form by Fax: 817-302-4337 Email: Market.Actions@Alcon.com at your earliest convenience. Alcon will reconcile the forms and communicate responses to Cardinal Health. No product return is requested. Please forward the attached Medical Device Correction notice to professionals within your organization who may be using Alcon Custom Pak surgical kits containing the affected Cardinal Health Salem Sump Tubing. Contact Alcon Customer Service at 1-800-862-5266 or contact your Alcon Sales Representative with questions or concerns.

Distribution

As reported by FDA

DE, IL, OK