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ICU Medical, Inc. recalls REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, U
Recalled May 13, 2020 · FDA recall Z-1914-2020 · ICU Medical
Hazard
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences. · FDA Class II
Units
350 units
Sold at
US:AK,AL,AR,AZ,CA,CO,CT,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,SD,TN,TX,UT,VA,WA,WI,WY OUS: Canada *** "REF" numbers AH7117 and B30211 were not marketed or distributed within the US***
Description
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
Product
REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →