GVS TM, Inc: SQ40S Blood Transfusion Filter

Recall number

Z-1157-2026

Recalling firm

GVS TM, Inc

Product

SQ40S Blood Transfusion Filter

Status

Open, Classified

Initiated

2025-11-03

Posted

2026-01-22

Terminated

not on file

Reason

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

Root cause

Process control

Action

On 11/03/2025, the firm sent via email a "GVS TM Inc Customer Statement" informing customers that GVS TM Inc discovered that some of the products in the affected lot may have been damaged during the transportation process. To avoid any potential risk this damage may pose to the downstream user, the firm is requesting return of the affected products. On 11/18/2025, the firm sent via email a "GVS TM Inc Product Recall Statements" informing customers that the products were distributed before completion of the required quality control release process, including final review of sterilization documentation and Certificate of Analysis. As a result the sterility assurance cannot be confirmed. Customers are instructed to: 1) Return all units of Lot 7536142 to GVS TM Inc - Customer Service using GVS TM FedEx Account 203742698, or 2) Destroy the affected units at their facility according to their internal disposal procedures for medical devices. 3) Confirmation Required - If Returning Product --Quantity returned --Date Shipped Back --Contact Person - If Destroying Product (Proof of Destruction Required) --Signed destruction confirmation --Statement on facility letterhead indicating: ---Quantity destroyed ---Date of Destruction ---Method of disposal ---Name/title of the person performing destruction Upon receipt of the above information, GVS TM Inc will issue replacements or credit depending on customer's preference. Questions - Contact GVS TM Customer Service at customerservice tm.na@gvs.com

Quantity

2,720 filters

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

Lot, serial or model codes

Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

510(k) numbers

["K960993"]

PMA numbers

not on file

Product code

CAK

Firm FEI

2013342

Firm city

Covina

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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