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Recall Observatory FDA recall evidence

Device product

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

Z-0621-2024

November 01, 2023

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 93553
Status
Ongoing
Classification
Class II
Quantity
835 cases total (6 units/case)
Official record key
device-enforcement:Z-0621-2024

Official wording

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.

Code information: UDI-DI 00650862110012 Lots 492065 and 492075

Distribution pattern: Domestic distribution nationwide. No foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.