FDA (Devices) recall action 85650
The FDA (Devices) publishes a recall like this one as 37 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 37 pages.
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
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.
CME America is recalling BodyGuard Microset infusion sets due to delivery inaccuracies that may cause over- or under-infusion of therapy.
CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.
CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
CME America is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.
CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.
CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard Microset infusion sets because they may deliver fluid at inaccurate rates, potentially causing over- or under-infusion of therapy.
CME America is recalling 13,280 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracies that may cause over- or under-infusion of therapy.