# FDA recall Z-3004-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-04-08.

## Product

Medline Convenience kits labeled as:    1) FETOSCOPY CDS-LF, Pack Number CDS840215O ;   2) BONE RETRIEVAL PART A , Pack Number CDS981237F ;   3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ;   4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239;   5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A;   6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A;   7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH;   8) PACK,BREAST BIOPSY, Pack Number DYNDL1498;   9) BONE MARROW PACK, Pack Number DYNJ0628436I ;   10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K;   11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH;   12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ;   13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH;   14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ;   15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ;   16) BIOPSY TRAY , Pack Number DYNJ31585C ;   17) BONE MARROW KIT PK, Pack Number DYNJ37526;   18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ;   19) C

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-3004-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-08
- **Report date:** 2024-09-18

- **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-3004-2024

## Citation

> AI Analytics. FDA recall Z-3004-2024. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-3004-2024. Source: US FDA. Licensed CC0.

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