Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process
Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile medical device with a compromised sterilization process that lacks manufacturer validation. This represents a risk-of-harm product where no illnesses have been reported, meeting the criteria for a High severity score.
Plain-English summary
Atrium Medical Corporation is recalling specific lots of the Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number 3600-100 (UDI-DI: 20650862110016).
The recalled devices were re-processed and re-sterilized by a third party using packaging configurations and a sterilization process that are not approved by the manufacturer and lack validation. This unauthorized re-sterilization may compromise the device's sterility assurance.
The affected lot numbers are: 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. The devices were distributed in Virginia.
The recalled product
- Product
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Hazard
- sterilization-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 20650862110016. Lots: 460793
- 461324
- 463567
- 463568
- 463569
- 466447
- 466945
- 466946
- 467473
- 467843
- 471055
- 471797
- 472571
- 474505
- 477919
- 480204
- 480205
- 480658
- 482038
- 483030
Distribution
Distributed in 1 state:
- VA
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