ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0193-2021)

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:

6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455; (01)10887709062525(17)241201(30)50(10)4537168; (01)10887709062525(17)241201(30)50(10)4493389. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.

Product Classification:

Class II

Date Initiated: July 6, 2020

Date Posted: October 28, 2020

Recall Number: Z-0193-2021

Event ID: 86054

Reason for Recall:

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Status: Terminated

Product Quantity: Total of all products (Listed #1 thru 101) = 304735 units

Code Information:

Lot Numbers:4558455, 4537168, 4493389.

Distribution Pattern:

Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated