ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1912-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211

Product Classification:

Class II

Date Initiated: October 4, 2019

Date Posted: May 13, 2020

Recall Number: Z-1912-2020

Event ID: 85053

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1000 units

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***

Voluntary or Mandated:

Voluntary: Firm initiated