Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Reason for recall: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada. Quantity: 12980 units Lot/code info: a) 66520, UDI/DI 60653160040960 (case) 00653160040968 (each), Lot Numbers: 2023111590; b) A547ST, UDI/DI 10653160113683 (case) 00653160113686 (each), Lot Numbers: 2023020990, 2023033090, 2023060790, 2023092990; c) I68080, UDI/DI 20653160232602 (case) 00653160232608 (each), Lot Numbers: 2023072790; d) I68085, UDI/DI 30653160232616 (case) 00653160232615 (each), Lot Numbers: 2023032290, 2023071790; e) I68095, UDI/DI 20653160232695 (case) 00653160232691 (each), Lot Numbers: 2023062690; f) ZC110ST, UDI/DI 00653160258462 (case) 10653160258469 (each), Lot Numbers: 2023022490, 2023041090, 2023052290, 2023062890
60653160040960, 00653160040968, 10653160113683, 00653160113686, 20653160232602, 00653160232608, 30653160232616, 00653160232615, 20653160232695, 00653160232691, 00653160258462, 10653160258469
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.