Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0621-2024 — Atrium Oasis Drain Single W / AC, Part No. 3600-100

U.S. FDA — Device Enforcement · United States · 2023-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0621-2024
Date of alert
2023-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Atrium Medical Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00650862110012
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.