Recall archive / FDA device enforcement
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMO... — FDA record Z-1438-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 80903 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1438-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 10, 2024
- Recall initiation date
- Feb 23, 2024
- Center classification date
- Mar 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.