—#204036

Product

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

FDA product code: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K043582
Affected lot / code info: UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.

Why it was 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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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).

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: US: VA

Timeline

Recall initiated: 2023-09-05
Posted by FDA: 2023-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204036. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.