# FDA recall Z-1438-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-02-23.

## 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) STERI

## 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.

## Key facts

- **Recall number:** Z-1438-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-23
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2024

## Citation

> AI Analytics. FDA recall Z-1438-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1438-2024. Source: US FDA. Licensed CC0.

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