Product Safety Recalls

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Atrium Medical Corporation Recall 93553

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

Atrium Medical Corporation Recall 93553 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0621-2024
Event ID93553
Event DescriptionAtrium Oasis Drain Single W / AC, Part No. 3600-100
Product TypeDevices
DistributionDomestic distribution nationwide. No foreign distribution.
Quantity835 cases total (6 units/case)
Recall ReasonA 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.
Device Classification20240103
Device Code InfoUDI-DI 00650862110012 Lots 492065 and 492075
Center Classification Date20231228
Recall Initiation Date20231101
Recalling FirmAtrium Medical Corporation
Initial Notification Letter
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