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GVS TM, Inc: SQ40S Blood Transfusion Filter

Medical DevicesSource: FDA (device) · Date: 2026-01-28

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GVS TM, Inc
Product
SQ40S Blood Transfusion Filter
Reason / hazard
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Classification
Class II
Status
Ongoing
Distribution / sold at
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
Recall initiated
2025-11-03
Code info
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Product quantity
2,720 filters
Voluntary mandated
Voluntary: Firm initiated
City
Covina
State
CA
Country
United States
Event id
98145
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