GVS TM, Inc recalled 2,720 SQ40S Blood Transfusion Filters on November 3, 2025. The recall follows concerns that the sterility assurance cannot be confirmed due to incomplete quality control processes. Healthcare providers and patients must stop using the device immediately.
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GVS TM, Inc or your healthcare provider for instructions. Notification method: E-Mail
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The SQ40S Blood Transfusion Filter is a medical device used to ensure the safety of blood transfusions by filtering out impurities. Hospitals and healthcare providers depend on its sterility for patient safety during transfusions.
The filters were released without completing the required quality control checks, compromising their sterility assurance. This increases the risk of infections during medical procedures involving blood transfusions.
This recall is not part of a broader industry pattern.
The recall could lead to significant safety concerns for patients requiring transfusions and may cause disruptions in medical facilities relying on the affected filters.
Look for the UDI-DI code and lot number on the device packaging or accompanying documentation.
Expect a response from GVS TM regarding refunds or replacements within 4-6 weeks.
Keep records of all communications regarding the recall, including emails, letters, and any response from GVS TM.
The affected product is the SQ40S Blood Transfusion Filter with UDI-DI code 10887691000666 and Lot Number 7536142. These filters were distributed in various U.S. states including Texas, California, and New York. No price was specified.
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