# FDA recall Z-2998-2024

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

## Product

Medline Convenience kits labeled as:   1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J;  2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ;  3) BIOPSY DRAPE PACK , Pack Number 00-400762H ;  4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ;  5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ;  6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ;  7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ;  8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B;  9) BREAST BIOPSY KIT , Pack Number BT1085A;  10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F;  11) BREAST/MINOR, Pack Number CDS980228X ;  12) BIOPSY CDS-LF , Pack Number CDS984667D ;  13) BIOPSY CDS-LF , Pack Number CDS984667F ;  14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ;  15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101;  17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960;  18) BIOPSY DEKALB PACK, Pack Number DM150A ;  19) INFECTION DRIVELINE MANAGEMENT KIT, Pack 

## 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-2998-2024
- **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-2998-2024

## Citation

> AI Analytics. FDA recall Z-2998-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2998-2024. Source: US FDA. Licensed CC0.

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