ICU Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1569-2021)

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 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets 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-1569-2021

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: CH2000S CH2000S-10 CH2000S-C CH2000SC-10 CH2000SC-5 CH2000SC-5 CH2050 UDI: (01) 1 0840619 033900 (17) 260101 (30) 100 (10) 5125299 (01) 1 0840619 03391 7 (17) 260101 (30) 50 (10) 5142922 (01) 1 0840619 02661 2 (17) 260101 (30) 50 (10) 5125303 (01) 1 0840619 04276 6 (17) 260101 (30) 50 (10) 5142969 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5125289 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5142945 (01) 1 0887709 12231 1 (17) 260101 (30) 25 (10) 5125288 Lot Number: 5125299 5142922 5125303 5142969 5125289 5142945 5125288

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