Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELLY HEMOSTAT, Product Code 67140; i) ST. STR MOSQUITO HEMOSTAT 3 1/2"(MHB700), Product Code 67325; j) STERILE CVD MOSQT HEMOST 3 1/2"(MHB710), Product Code 67330; k) STERILE 8" CRVD KELLY HEMOSTAT (CK1008), Product Code 67655; l) STERILE 8" STR KELLY HEMOSTAT (SK1008), Product Code 67660; m) ST MOSQUITO HEMO CURVED FINE PT (P/S), Product Code I68100; n) ST CURVED KELLY HEMOSTAT-TAMPA GEN, Product Code I68310; o) STERILE STRT KELLY HEMOSTAT (ZM-09417), Product Code P-65240; p) STERILE STRT MOSQUITO HEMOSTAT (MHS102), Product Code TRI66140; q) STERILE CURVED KELLY HEMO (ST153), Product Code TRI66765
This recall is currently active, issued March 29, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 23, 2024
- Posted
- March 29, 2024
- Recall Number
- Z-1438-2024
- Quantity
- 80903 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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) 10653160317852 (each), Lot Numbers: 2023032890, 2023061690; q) TRI66765, UDI/DI 00653160317947 (case) 10653160317944 (each), Lot Numbers: 2023030990
Root Cause
Process control
Action Taken
Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.