# FDA recall Z-1437-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-02-11.

## Product

Medline procedure kits labeled as:    1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D;   2) ANGIO PACK, Pack Number DYNJ69678;   3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A;   4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C;   5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A;   6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N;   7) ARTERIOGRAM PACK, Pack Number DYNJ34442F;   8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I;   9) CARDIAC CATH PACK, Pack Number DYNJ31733C;   10) CARDIAC CATH PACK, Pack Number DYNJ41315A;   11) CARDIAC CATH PACK-LF, Pack Number DYNJ0380198L;   12) CATH LAB PACK, Pack Number 0M-CP31796Q;   13) CATH LAB PACK-LF, Pack Number DYNJ0194968AG;   14) CATH LAB TRAY, Pack Number 00-401610J;   15) CHRISTUS SR CATH LAB PACK, Pack Number DYNJ60931C;   16) CRMC CATH LAB TRAY JUDKINS-LF, Pack Number DYNJ61088F;   17) CRMC NEURO ENDO HYBRID-LF, Pack Number DYNJ61101D;   18) EP PACK MORNINGSIDE, Pack Number DYNJ69301;   19) FEMORAL TRAY 2, Pack Number DYNJ688

## 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 - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1437-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-11
- **Report date:** 2025-04-02

- **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-1437-2025

## Citation

> AI Analytics. FDA recall Z-1437-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1437-2025. Source: US FDA. Licensed CC0.

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