# FDA recall Z-2743-2024

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

## Product

Medline procedural kits labeled as:    1) OPEN HEART PEDS, Pack Number CDS981050Q;   2) OPEN HEART CDS, Pack Number CDS982411N;   3) OPEN HEART, Pack Number CDS983348AA;   4) OPEN HEART, Pack Number CDS983348X;   5) OPEN HEART, Pack Number CDS983348Y;   6) HMT CV SET UP CDS, Pack Number CDS984206R;   7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P;   8) OPEN HEART A&B PACK, Pack Number CMPJ02162I;   9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J;   10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C;   11) VASCULAR PACK, Pack Number CMPJ08949F;   12) BOISE HEART PACK-LF, Pack Number CMPJ09225F;   13) VASCULAR PACK, Pack Number CMPJ09236D;   14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F;   15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C;   16) CAROTID PACK, Pack Number CMPJ10797B;   17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A;   18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B;   19) VASCULAR PACK, Pack Number CMPJ13632;   20) OPEN HEART DRAPE PACK-LF, Pack Number DYN

## 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

## Key facts

- **Recall number:** Z-2743-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-08
- **Report date:** 2024-09-04

- **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-2743-2024

## Citation

> AI Analytics. FDA recall Z-2743-2024. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-2743-2024. Source: US FDA. Licensed CC0.

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