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FDA (Device enforcement)Recalled 2025-11-03class ii

GVS TM, Inc: SQ40S Blood Transfusion Filter

Hazard

Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Details from the source

Reason for recall: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. Distribution: U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA Quantity: 2,720 filters Lot/code info: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

UPC codes

10887691000666

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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