Chest Drain Devices Re-sterilized Using Unapproved Process
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
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: This is an FDA Class II medical device recall where the primary hazard stems from compromised sterilization validation. Although no illnesses or injuries have been reported in the source text, chest drain devices are critical sterile medical products used in direct patient contact. The use of unapproved and unvalidated sterilization processes presents a direct risk of harm through potential contamination or infection.
Plain-English summary
Atrium Medical Corporation has recalled Atrium Oasis Dry Suction Water Seal Chest Drain devices (Part Number 3650-100) due to unauthorized re-sterilization performed by a third party. The recalled devices were re-processed and re-sterilized using packaging configurations and sterilization processes that were not approved by the manufacturer and lack proper validation.
The affected products carry UDI-DI 20650862113017 and include lot numbers 461817, 467572, 468617, 468855, 467191, 467849, 469401, and 479253. These devices were distributed in Virginia.
The primary concern is that the unapproved sterilization process and packaging configuration may have compromised the sterility of the devices. Patients currently using these chest drains should consult their healthcare provider immediately to discuss their care and whether their device should be replaced.
The recalled product
- Product
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
- Manufacturer
- Atrium Medical Corporation
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 (8)
- UDI-DI: 20650862113017. Lots: 461817
- 467572
- 468617
- 468855
- 467191
- 467849
- 469401
- 479253.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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