# FDA recall Z-0621-2024

> **Atrium Medical Corporation** · Class II · device recall initiated 2023-11-01.

## Product

Atrium Oasis Drain Single W / AC, Part No. 3600-100

## Reason for recall

A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

## Distribution

Domestic distribution nationwide. No foreign distribution.

## Key facts

- **Recall number:** Z-0621-2024
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-01
- **Report date:** 2024-01-03

- **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-0621-2024

## Citation

> AI Analytics. FDA recall Z-0621-2024. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0621-2024. Source: US FDA. Licensed CC0.

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