# FDA recall Z-3030-2024

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

## Product

Medline Convenience kits labeled as:    1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ;   2) BREAST BIOPSY TRAY, Pack Number MNS5070;   3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A;   4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A;   5) BREAST BIOPSY TRAY, Pack Number SPEC0130B;   6) BIOPSY PACK SM, Pack Number DYNDH1093;   7) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   8) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;   9) LACERATION TRAY, Pack Number DYNDL1250C;   10) PULL D/C PACK, Pack Number DYNDA2080;   11) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   12) OB DELIVERY SET, Pack Number MNS3355;   13) SUTURING SET, Pack Number SUT4020;   14) 22G FACET TRAY, Pack Number SPEC0265A;   15) ARTHROGRAM TRAY, Pack Number DYNDH1349;   16) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B;   17) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496;   18) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   19) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   20) BREAST BIOPSY KIT, Pack Number

## 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-3030-2024
- **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-3030-2024

## Citation

> AI Analytics. FDA recall Z-3030-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3030-2024. Source: US FDA. Licensed CC0.

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