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 200 Clave Bag Spikes with ChemoLock port 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 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 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports 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 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 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 16,850 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 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, 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 950 21-inch 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 1,700 Graduated Connectors with ChemoLock port 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.
ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port 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 134,700 ChemosafeLock Bag Spikes 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 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 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.