Summary
The FDA issued a Class II for SQ40S Blood Transfusion Filter by GVS TM, Inc. Reason: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be .
Details
Source
Device Recall
External ID
Z-1157-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
Product Description
SQ40S Blood Transfusion Filter
Lot/Code Info: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Quantity Affected: 2,720 filters
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-03
Company
Covina, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GVS TM, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GVS TM, Inc have FDA actions?
This is the only FDA action we have on record for GVS TM, Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1157-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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