Atrium Oasis Drain Single W / AC, Part No. 3600-100
Reported: January 3, 2024 Initiated: November 1, 2023 #Z-0621-2024
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.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 835 cases total (6 units/case)
- Distribution
- Domestic distribution nationwide. No foreign distribution.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Atrium Oasis Drain Single W / AC, Part No. 3600-100. Recalled by Atrium Medical Corporation. Units affected: 835 cases total (6 units/case).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2024. Severity: Moderate. Recall number: Z-0621-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11