Reported Nov 27, 2024 · Ongoing
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;…
Alcon Research LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR |
| 2 | Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR |
| 3 | VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR |
| 4 | VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 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. 2 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. 3 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. 4 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. - Amount recalled
- 3486 surgical kits
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Alcon Research LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.