FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Recall number
- Z-2199-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Status
- Open, Classified
- Initiated
- 2025-06-16
- Posted
- 2025-07-30
- Terminated
- not on file
- 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.
- 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
- 1,427,100 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- Lot, serial or model codes
- UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
- 510(k) numbers
- ["K130975"]
- PMA numbers
- not on file
- Product code
- QBP
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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