Recall Z-0621-2024— Atrium Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-11-01. It names one FDA 510(k) clearance: K043140. Product: Atrium Oasis Drain Single W / AC, Part No. 3600-100. Reason: 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..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-01
- Firm location
- Merrimack, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.