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

Recall date

October 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0490-2025

FDA classification

Class III

Brand / firm

Alcon Research LLC

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.