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: 84224 units Lot/code info: a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers: 2023060790, 2023101090; b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers: 2023022790, 2023041190; c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers: 2023112790; d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers: 2023022490, 2023041990, 2023102690; e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers: 2023031690, 2023111490; f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers: 2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990
60653160008380, 00653160008388, 60653160010208, 00653160010206, 60653160008793, 00653160008791, 50653160007188, 00653160007183, 50653160001766, 00653160001761, 10653160317975, 20653160317972
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.