ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0707-2021)

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:

31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger, REF: CL3962; 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger, REF: CL3999

Product Classification:

Class II

Date Initiated: August 31, 2020

Date Posted: December 30, 2020

Recall Number: Z-0707-2021

Event ID: 86426

Reason for Recall:

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Status: Ongoing

Product Quantity: 88700

Code Information:

Lots: 4867937, 4751234, 4799262, 4894789, 4787230, 4867947, 4897075, 4720480, 4735684, 4758456, 4775068, 4794504, 4860043, 4799897, 4787234, 4808045, 4860044 ,

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated