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.

Class I - Dangerous

🏥 Medical Devices Recalled: October 15, 2024 Alcon Research Other Medical Devices

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.