Class 3 Device Recall Alcon CustomPak surgical kits

• Date Initiated by Firm: October 15, 2024
• Date Posted: November 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0490-2025
• Recall Event ID: 95599
• Product Classification: Eye tray - Product Code OJK
• Product: 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.
• Code Information: UDI-DI: +H5301ALCON1CPAK10 a) Custom Pak # 15340-11: (Lot, Exp) JZ5221212, 2025-02-28; JZ5221710, 2025-02-28; 16PETC, 2025-03-31; 1704TA, 2025-03-31; 16TENC, 2025-07-31; 16UDE9, 2025-07-31; 16WL8F, 2025-07-31; 16X6FE, 2025-07-31. b) Custom Pak # 6557-59: (Lot, Exp) 2326720H, 2022-02-13; 2333628H, 2022-05-14. Custom Pak # 6557-60: (Lot, Exp) JZ5020496, 2020-10-31; JZ5033702, 2021-03-31; JZ5053771, 2021-12-31; JZ5054044, 2022-01-31; 2343441H, 2022-02-04; 2425727H, 2022-03-13; JZ5070889, 2022-04-30; 2403037H, 2022-05-23; JZ5079439, 2022-05-31; JZ5080320, 2022-05-31; JZ5080898, 2022-05-31; JZ5082125, 2022-05-31; 14VWFU, 2024-12-31; 16DVFW, 2025-02-28; 16R6HM, 2026-01-31; JZ5190740, 2026-02-28. c) Custom Pak # 9456-59: (Lot, Exp) 2328788H, 2021-09-24; 2326181H, 2021-10-29; 2335667H, 2022-01-22; 2337915H, 2022-01-22; 2330901H, 2022-02-13; 2360751H, 2022-02-13; 2332968H, 2022-05-01. Custom Pak # 9456-60: (Lot, Exp) 2377532H, 2022-02-13; 2433004H, 2022-03-13; 2435844H, 2022-03-31; 2438674H, 2022-03-31; 2443455H, 2022-03-31; 2389892H, 2022-05-23; 2402383H, 2022-05-23; 2409316H, 2022-05-23; 2454167H, 2022-05-31; 2391155H, 2022-06-01; 2394641H, 2022-07-08; 2475011H, 2022-07-31. Custom Pak# 9456-61: (Lot, Exp) 2479674H, 2022-05-31; 2510964H, 2022-05-31; 2517601H, 2022-05-31; 2518895H, 2022-05-31; 2502011H, 2022-09-30; 2503593H, 2022-09-30; 2526469H, 2024-03-31; 2530562H, 2024-05-31; 14C3WK, 2024-06-30; 14FY80, 2024-10-31. d) Custom Pak # 12216-12: (Lot, Exp) 2326566H, 2021-08-01; 2329339H, 2021-08-01; 2336115H, 2021-10-01; 2388598H, 2022-06-01; 2384136H, 2022-06-17. Custom Pak # 12216-14: (Lot, EXP) 2401018H, 2022-05-23; 2454202H, 2022-05-31; 2482431H, 2022-06-30; 2458169H, 2022-07-31. Custom Pak # 12216-15: (Lot, Exp) JZ5079827, 2022-05-31; JZ5082848, 2022-05-31; JZ5083055, 2022-05-31; JZ5091224, 2022-08-31; JZ5092309, 2022-08-31; JZ5131291, 2023-03-31; JZ5131748, 2023-03-31; JZ5133797, 2023-08-31; JZ5139090, 2023-08-31; JZ5141753, 2023-08-31; JZ5143948, 2023-08-31; JZ5147454, 2023-08-31; JZ5150525, 2023-12-31; JZ5158900, 2023-12-31; 149JHU, 2024-10-31; 15506R, 2024-11-30; 156MR9, 2025-02-28; JZ5187273, 2025-03-31; JZ5187291, 2025-03-31; 15EU0H, 2025-04-30; JZ5187317, 2025-06-30; JZ5194024, 2025-06-30; JZ5195056, 2025-06-30; JZ5204449, 2025-06-30; JZ5211716, 2025-06-30; 15YK89, 2025-07-31; 15KPMM, 2025-08-31; 15KPN5, 2025-08-31; 15TLUR, 2025-09-30; 160631, 2025-10-31; 160DHT, 2025-10-31; 15Y1WT, 2025-12-31; 16D216, 2025-12-31; 16DXHT, 2026-05-31; 16FC7T, 2026-05-31; 16FVYR, 2026-09-30; 16J56N, 2026-09-30; 16JE01, 2026-09-30; 16KFYW, 2026-09-30.
• FEI Number: 1610287
• Recalling Firm/ Manufacturer: Alcon Research LLC; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Kristen Kellerhals; 817-551-4047
• Manufacturer Reason for Recall: Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
• FDA Determined Cause: Use error
• Action: 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.
• Quantity in Commerce: 3486 surgical kits
• Distribution: US distribution to states of: Delaware, Illinois, and Oklahoma
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.