Recall Z-0485-2024
Atrium Medical Corporation · initiated September 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Codes / lots: UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762.
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.
FDA-determined cause: Labeling mix-ups
Action taken
The recall notification was issued via Fed-Ex and email on October 5, 2023. It requests (1) immediate quarantine and return of all affected product inventory on hand. (2) for any product further distributed, notify customers that have received affected product to remove the affected devices from use and return them. Questions may be addressed to your Getinge representative or call Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Details
- Recall number
- Z-0485-2024
- Initiated
- September 5, 2023
- Posted by FDA
- December 2, 2023
- Product code
- KDQ – Bottle, Collection, Vacuum
- Distribution
- US: VA
- Recalling firm
- Atrium Medical Corporation, Merrimack, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0486-2024 Class II | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU…Product was re-processed and re-sterilized by a third party using packaging configurations and a… | 09/05/2023Open, Classified |