Summary
The FDA issued a Class II for Atrium Oasis Drain Single W / AC, Part No. 3600-100 by Atrium Medical Corporation. Reason: A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonco.
Details
Source
Device Recall
External ID
Z-0621-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Lot/Code Info: UDI-DI 00650862110012 Lots 492065 and 492075
Quantity Affected: 835 cases total (6 units/case)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-01
Company
Merrimack, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 94 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0621-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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