Device product
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Z-0235-2023
Product summary
- Event
- Event 91043
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units (4cases/6)
- Official record key
device-enforcement:Z-0235-2023
Official wording
Reason: Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
Code information: UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
Distribution pattern: US Nationwide distribution in the state of VA.
Derived failure modes
-
Unknown
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.