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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Oasis Drain Single W / AC

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  Class 2 Device Recall Atrium Oasis Drain Single W / AC see related information
Date Initiated by Firm November 01, 2023
Date Posted December 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-0621-2024
Recall Event ID 93553
510(K)Number K043140  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product Atrium Oasis Drain Single W / AC, Part No. 3600-100
Code Information UDI-DI 00650862110012 Lots 492065 and 492075
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact Jessica Minaya
603-880-1433
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On November 1, 2023, the firm issued URGENT MEDICAL DEVICE - Removal letters to affected customers. Customers were instructed to remove any product from the affected lots from areas of use. Customers with affected product are entitled to a replacement at no cost to their facility. Customers will receive replacements upon their acknowledgement that they have affected product for return. Distributors should forward recall documentation to affected customers. Customers with questions may contact their Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, 9AM-6PM Eastern Time Zone.
Quantity in Commerce 835 cases total (6 units/case)
Distribution Domestic distribution nationwide. No foreign distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = ATRIUM MEDICAL CORP.
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