Z-2199-2025Class II

SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

Name: Z-2199-2025 SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-06-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-06-16 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301 on 2025-06-16. FDA classified it as Class II and gives the reason as "SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may...". 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-2199-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-16
Posted: 2025-07-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Product code: QBP Cap, Device Disinfectant
Reason for recall: SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
Quantity in commerce: 1,427,100 eaches
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Product codes and lots: UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2199-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2199-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-30

Product code QBP

K130975Class IISwabcap and SwabflushExcelsior Medical Corp. / cleared 2013-12-24

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)