# FDA recall Z-0486-2024

> **Atrium Medical Corporation** · Class II · device recall initiated 2023-09-05.

## Product

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

## Reason for recall

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

## Distribution

US: VA

## Key facts

- **Recall number:** Z-0486-2024
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-05
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2024

## Citation

> AI Analytics. FDA recall Z-0486-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0486-2024. Source: US FDA. Licensed CC0.

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