# FDA recall Z-1438-2025

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

## Product

Medline procedure kits labeled as:    1) AV FISTULA PACK, Pack Number DYNJ80088;   2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J;   3) CABG, Pack Number DYNJ906462B;   4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U;   5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;   6) CARDIAC CATH PACK, Pack Number DYNJ61256A;   7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527;   8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C;   9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F;   10) CAROTID PACK, Pack Number DYNJ0810062AI;   11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T;   12) CATH PACK, Pack Number DYNJ59830A;   13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B;   14) CICC, Pack Number DYNJ53854A;   15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G;   16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235;   17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F;   18) EP DEVICE, Pack Number DYNJ65916B;   19) EP STUDY PACK-LF, Pack Number DYNJ38059A;   20) FHZ PACEMAKER PACK, Pack Nu

## 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-1438-2025
- **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-1438-2025

## Citation

> AI Analytics. FDA recall Z-1438-2025. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-1438-2025. Source: US FDA. Licensed CC0.

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