FDA (Devices) recall action 97583
The FDA (Devices) publishes a recall like this one as 38 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 38 pages.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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 6,450 6.5-inch bag spikes with ChemoLock additive port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 6,150 ChemoLock Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 200 73-inch smallbore extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 80 units of ChemoLock Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 2,100 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 200 Oncology Kits with two ChemoLock components because the port weld of the drug transfer device may separate or break during use and leak.