MEDLINE INDUSTRIES, LP - Northfield: (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell

Hazard

Product has been identified as having holes in the packaging.

Details from the source

Reason for recall: Product has been identified as having holes in the packaging. Distribution: Worldwide distribution - US Nationwide and the countries of India and Panama. Quantity: 498,354 kits Lot/code info: (1) Reorder #200CR - lot numbers 2021100190, 2021121390, 2022012090, and 2023071801; UDI-DI each - 10653160278139; UDI-DI case - 10653160278139; (2)Reorder #210CR - lot numbers 2022081901, 2023071901, 2023091101, 2023110801, and 2024012901; UDI-DI each - 00653160197440; UDI-DI case - 10653160197447; (3) Reorder #230CR - lot numbers 2021100190, 2021121690, 2023071801, 2023090501, 2023103001, 2023111301, 2023112101, 2024010301, 2024012401, and 2024020190; UDI-DI each - 00653160197457; UDI-DI case - 10653160197454; (4) Reorder #245CR - lot numbers 2021102590, 2023071901, 2023083001, 2023100401, 2023101201, 2023103001, 2023111001, 2023112101, 2024011701, 2024030501, and 2024041801; UDI-DI each - 00653160197464; UDI-DI case - 10653160197461; (5) Reorder #310CR - lot numbers 2021100590, 2021101190, 2022050401, 2022050601, 2022081201, 2022112801, 2022120101, 2023012401, 2023031501, 2023032101, 2023040601, 2023040701, 2023041201, 2023041401, 2023041701, 2023042101, 2023042401, 2023042501, 2023042701, 2023042801, 2023050401, 2023050501, 2023050901, 2023051801, 2023112001, 2023121101, 2023121901, 2023122901, 2024010801, 2024011001, 2024012590, 2024021201, 2024022001, 2024022701, 2024030401, 2024030601, 2024031101, 2024031501, 2024031801, 2024032101, 2024032601, 2024040301, 2024041001, 2024041201, and 2024042201; UDI-DI each - 00653160197471; UDI-DI case - 10653160197478; (6) Reorder #310CRK - lot numbers 2021092490, 2021092990, 2021101190, 2021102890, 2021110590, 2021120690, 2021120990

UPC codes

10653160278139, 00653160197440, 10653160197447, 00653160197457, 10653160197454, 00653160197464, 10653160197461, 00653160197471, 10653160197478, 10653160309895, 00653160309898, 00653160197495, 10653160197492, 10653160309901, 00653160309904, 00653160197501, 10653160197508, 00653160197488, 10653160197485, 10653160312932, 00653160312935, 10653160312895, 00653160312898, 10653160312901, 00653160312904, 10653160312949, 00653160312942, 10653160312956, 00653160312959

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.