Food, drugs, devices › MEDLINE INDUSTRIES, LP - Northfield
Device recall: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
FDA enforcement event 97169 is a device recall by MEDLINE INDUSTRIES, LP - Northfield of Northfield, IL, initiated 16 Jun 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. MEDLINE INDUSTRIES, LP - Northfield has 120 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
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."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada and Panama."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2199-2025 | SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301 | 1,427,100 eaches | Class II | Ongoing | 6 Aug 2025 |
Context
Other enforcement events for MEDLINE INDUSTRIES, LP - Northfield
All 120 events for MEDLINE INDUSTRIES, LP - Northfield
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada and Panama."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.