Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT — Class II medical device recall Z-1438-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-04-10, distributed nationwide. Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The
| Recall number | Z-1438-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-02-23 |
| Classified | 2024-03-29 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 80,903 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00653160008784, 00653160023770, 00653160024036, 00653160024869, 00653160029208, 00653160038026, 00653160039573, 00653160049879, 00653160110678, 00653160110739, 00653160196009, 00653160196016, 00653160235814, 00653160278835, 00653160317855, 00653160317947, 10653160038023, 10653160110675, 10653160196006, 10653160196013, 10653160235811, 10653160278832, 10653160317852, 10653160317944, 10653160359234 and 9 more |
| Lot numbers | 2023022190, 2023030290, 2023030990, 2023031090, 2023031390, 2023032890, 2023041090, 2023041190, 2023041790, 2023042490, 2023042690, 2023042790, 2023042890, 2023050990, 2023060790, 2023061290, 2023061690, 2023070390, 2023071090, 2023072790, 2023082490, 2023090790, 2023091190, 2023101990, 2023103090, 2023112990, 2023120590 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1438-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.