ICU Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1582-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: 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: March 16, 2021

Date Posted: May 19, 2021

Recall Number: Z-1582-2021

Event ID: 87703

Reason for Recall:

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Status: Ongoing

Product Quantity:

Code Information:

REF: 011-H2864-HSR UDI: (01) 0 0840619 03268 5 (17) 260101 (30) 01 (10) 5142887 Lot Number: 5142887

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated