Device product
REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
Z-1912-2020
Product summary
- Event
- Event 85053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 units
- Official record key
device-enforcement:Z-1912-2020
Official wording
Reason: 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.
Code information: Lot # 4168832 *Product not distributed within the US
Distribution pattern: 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***
Derived failure modes
-
Unknown
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.