# FDA recall Z-3021-2024

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

## Product

Medline Convenience kits labeled as:    1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915;   2) PORT ACCESS TRAY, Pack Number DYNDC1318D;   3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ;   4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ;   5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ;   6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ;   7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ;   8) STERILE STARTER SET PACK, Pack Number DYNJ47814;   9) IVF PACK, Pack Number DYNJ63783;   10) VI PACK , Pack Number DYNJ64811;   11) VI PACK , Pack Number DYNJ64871;   12) IR CENTRAL KIT, Pack Number DYNJ68285;   13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011;   14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012;   15) LACERATION TRAY, Pack Number SUT20955;   16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225;   18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ;   19) UMBILICAL TRAY W/3.5&5FR CATH ,

## 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-3021-2024
- **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-3021-2024

## Citation

> AI Analytics. FDA recall Z-3021-2024. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-3021-2024. Source: US FDA. Licensed CC0.

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