Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
This recall is currently active, issued December 2, 2023. It was issued by Atrium Medical Corporation.
- Company
- Atrium Medical Corporation
- Recall Initiated
- September 5, 2023
- Posted
- December 2, 2023
- Recall Number
- Z-0486-2024
- Firm Location
- Merrimack, NH
- Official Source
- View on FDA website ↗
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.
Distribution
US: VA
Lot / Code Info
UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.
Root 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).