Z-0235-2023 Class II Ongoing
FDA device recall Z-0235-2023 was initiated by Atrium Medical Corporation on Oct 18, 2022 and is designated Class II. Reason for recall: Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients. The recall status is ongoing. Affected quantity: 24 units (4cases/6).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2022
- Initiation Date
- Oct 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units (4cases/6)
Product Description
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Reason for Recall
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
Distribution Pattern
US Nationwide distribution in the state of VA.
Code Information
UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0235-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026