ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0210-2021)

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:

13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

Product Classification:

Class II

Date Initiated: July 6, 2020

Date Posted: October 28, 2020

Recall Number: Z-0210-2021

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:4557533, 4572968.

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