Z-1157-2026Class II

SQ40S Blood Transfusion Filter

Name: Z-1157-2026 SQ40S Blood Transfusion Filter
Creator: GVS TM, Inc
Published: 2025-11-03
License: https://open.fda.gov/license/

GVS TM, Inc / initiated 2025-11-03 / Open, Classified / root cause: manufacturing process

FDA source

GVS TM, Inc began a recall of SQ40S Blood Transfusion Filter on 2025-11-03. FDA classified it as Class II and gives the reason as "Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1157-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-03
Posted: 2026-01-22
Recalling firm: GVS TM, Inc
Product: SQ40S Blood Transfusion Filter
Product code: CAK Microfilter, Blood Transfusion
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.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 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
Product codes and lots: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-22

Product code CAK

K960993Class IIPall Sq40s Blood Filter (Sq40s/sq40st)Pall Biomedical Products Co. / cleared 1996-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)