SwabFlush prefilled syringes carry SwabCaps with a compromised seal
SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.
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: Risk-of-harm product: reduced disinfection of a luer access valve, which the notice links to potential patient infection, with none reported.
Plain-English summary
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10 mL, model number EMZE010301, is being recalled. The action covers 1,427,100 eaches, UDI-DI 00363807103016 for each unit, 10363807103013 for the box and 20363807103010 for the case, across the lots listed in the recall notice.
According to the notice, 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 SwabCap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada and Panama.
Facilities should identify affected stock using the model number, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,427,100
Distribution
Distributed nationwide across the United States.
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