SwabFlush Prefilled Syringe with Faulty Disinfecting Cap Poses Infection Risk
Defective SwabCaps on SwabFlush prefilled syringes may reduce disinfection of luer access valves, potentially causing patient infection. The recall affects 1,427,100 units distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a defect that could result in patient infection or sepsis. Per the severity rubric, recalls with risk of serious harm but no reported illnesses or injuries are classified as High (score 3).
Plain-English summary
SwabFlush Prefilled Syringes with ICU Medical SwabCaps (Model EMZE010301, 10mL) are being recalled due to a manufacturing defect in the SwabCap disinfecting caps.
The issue involves a seal defect between the foil lid and plastic container of the SwabCap. This defect may result in a reduced level of disinfection of the luer access valve, potentially leading to patient infection or sepsis.
The recall affects 1,427,100 units distributed nationwide in the United States, as well as in Canada and Panama. The affected lots include numbers 3144609, 3144857, 3144886, 3144967, 3145090, and 3145186.
Consumers and healthcare providers should discontinue use of affected units and contact MEDLINE INDUSTRIES, LP for return or replacement instructions. No illnesses or injuries have been reported to date.
The recalled product
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- infection-risk
- inadequate-disinfection
Distribution
Distributed nationwide across the United States.
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