FDA (Devices) recall action 85361
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Inability for the guidewire to pass through the needles included with the catheter kits.
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 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.
ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.
ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.
ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.