FDA (Devices) recall action 73391
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing 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 specific I.V. infusion administration sets because a connection may develop a leak.
ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the connection may develop a leak.
ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and ChemoLock port may develop a leak.
ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.
ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.
ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.
ICU Medical is recalling specific IV administration sets with ChemoLock ports because the connection may develop a leak.
ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.