FDA Device recall Z-2199-2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no by Medline Industries Northfield, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2199-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-16 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Reason
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.
Identifiers
| code_info | UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2025%22
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