FDA (Devices) recall action 86426
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.
ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.
ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.
ICU Medical is recalling 325 units of 30-inch IV administration sets because a molding defect in the male luer may cause fluid leaks, potentially leading to infusion delays or contamination.
ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.