a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;

FDA device recall Z-0490-2025 · posted 2024-11-19 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

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

Action taken

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.

Root cause

Use error

Status

Open, Classified

Product code

OJK

Quantity affected

3486 surgical kits

Distribution

US distribution to states of: Delaware, Illinois, and Oklahoma

Date initiated

2024-10-15

Date posted

2024-11-19

Location

Fort Worth, TX