FDA recall Z-0486-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-09-05

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2024