Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Brand
Atrium Medical Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Atrium Medical Corporation is recalling Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 36 due to Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026