Device product
SQ40S Blood Transfusion Filter
Z-1157-2026
Product summary
- Firm
- GVS TM, Inc
- Event
- Event 98145
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,720 filters
- Official record key
device-enforcement:Z-1157-2026
Official wording
Reason: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Code information: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Distribution pattern: 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
Derived failure modes
-
Sterility assurance
sterility assurance cannot be confirmed