Atrium Oasis Dry Suction Water Seal Chest Drain recall
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Why was Atrium Oasis Dry Suction Water Seal Chest Drain recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.
- Product
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
- Recalling firm
- Atrium Medical Corporation
- Distribution
- US: VA
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)