Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Reason for recall: Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. Distribution: US distribution to states of: Delaware, Illinois, and Oklahoma Quantity: 3486 surgical kits Lot/code info: 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; 2329339
Official record: FDA (Device enforcement) ↗
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