Recall archive / FDA device enforcement
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 F... — FDA record Z-0490-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Classification
- Class III
- Recalling firm
- Alcon Research LLC
- Quantity
- 3486 surgical kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0490-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: Delaware, Illinois, and Oklahoma
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 15, 2024
- Center classification date
- Nov 19, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.