# FDA recall Z-3107-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-06-27.

## Product

Medline convenience kits containing semi-rigid suction liners labeled as follows:    a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I;   b) ENDO KIT, Pack Number DYKE1558B;   c) ENDO KIT, Pack Number DYKE1804A;   d) VASCULAR-LF, Pack Number DYNJ900714C;   e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B;   f) AV FISTULA, Pack Number DYNJ908096A

## Reason for recall

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

## Key facts

- **Recall number:** Z-3107-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-27
- **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-3107-2024

## Citation

> AI Analytics. FDA recall Z-3107-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3107-2024. Source: US FDA. Licensed CC0.

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