FDA recall Z-0621-2024

Atrium Medical Corporation · Class II · device

Product

Atrium Oasis Drain Single W / AC, Part No. 3600-100

Reason for recall

A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

Distribution

Domestic distribution nationwide. No foreign distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-01
Report date
2024-01-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0621-2024