FDA-Device2026-01-28Class IIPROCESSING DEFECT
GVS SQ40S Blood Transfusion Filter recalled for unconfirmed sterility
What this means
GVS released 2,720 SQ40S blood transfusion filters without completing required quality control testing. Because the sterility verification process was not finished, the company cannot confirm these filters are safe to use. The affected lot number is 7536142.
- Stop using SQ40S filters (lot 7536142, UDI-DI: 10887691000666) immediately
- Contact your blood bank or medical facility to report any filters already in use
- Do not use filters from this lot for any transfusions
- Contact GVS or the FDA with questions about replacement or returns
The agency's original wording
Hazard
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Intended for
All ages
Illnesses reported
None reported
Sold states
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
Affected count
2,720 filters
Manufactured in
1630 W Industrial Park St, Covina, CA, United States
Products
SQ40S Blood Transfusion Filter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1157-2026Want us to check the next one for you?
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