MEDLINE INDUSTRIES, LP - Northfield: Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE

Hazard

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.

Details from the source

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: 80903 units Lot/code info: a) 65340, UDI/DI 10653160038023 (case) 00653160038026 (each), Lot Numbers: 2023041090, 2023061290, 2023091190; b) 66145, UDI/DI 70653160008783 (case) 00653160008784 (each), Lot Numbers: 2023042690, 2023042790, 2023072790; c) 66170, UDI/DI 70653160024035 (case) 00653160024036 (each), Lot Numbers: 2023031090, 2023041790; d) 66175, UDI/DI 60653160039575 (case) 00653160039573 (each), Lot Numbers: 2023031390, 2023050990, 2023082490, 2023103090; e) 66445, UDI/DI 70653160023779 (case) 00653160023770 (each), Lot Numbers: 2023070390, 2023071090; f) 66485, UDI/DI 60653160029200 (case) 00653160029208 (each), Lot Numbers: 2023042690, 2023090790; g) 66695, UDI/DI 60653160024861 (case) 00653160024869 (each), Lot Numbers: 2023042790; h) 67140, UDI/DI 60653160049871 (case) 00653160049879 (each), Lot Numbers: 2023112990; i) 67325, UDI/DI 10653160110675 (case) 00653160110678 (each), Lot Numbers: 2023042490; j) 67330, UDI/DI 30653160110730 (case) 00653160110739 (each), Lot Numbers: 2023042890; k) 67655, UDI/DI 10653160196006 (case) 00653160196009 (each), Lot Numbers: 2023030290; l) 67660, UDI/DI 10653160196013 (case) 00653160196016 (each), Lot Numbers: 2023031390, 2023101990; m) I68100, UDI/DI 10653160235811 (case) 00653160235814 (each), Lot Numbers: 2023041190, 2023060790; n) I68310, UDI/DI 00653160278835 (case) 10653160278832 (each), Lot Numbers: 2023022190; o) P-65240, UDI/DI 10653160359234 (case) 20653160359231 (each), Lot Numbers: 2023120590; p) TRI66140, UDI/DI 00653160317855 (case) 10653

UPC codes

10653160038023, 00653160038026, 70653160008783, 00653160008784, 70653160024035, 00653160024036, 60653160039575, 00653160039573, 70653160023779, 00653160023770, 60653160029200, 00653160029208, 60653160024861, 00653160024869, 60653160049871, 00653160049879, 10653160110675, 00653160110678, 30653160110730, 00653160110739, 10653160196006, 00653160196009, 10653160196013, 00653160196016, 10653160235811, 00653160235814, 00653160278835, 10653160278832, 10653160359234, 20653160359231, 00653160317855, 10653160317852, 00653160317947, 10653160317944

Source

Official record: FDA (Device enforcement) ↗

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