Home / Recalls / ICU Medical, Inc. / Z-0707-2021

Z-0707-2021 Class II Ongoing

Recalled by ICU Medical, Inc. — San Clemente, CA

FDA device recall Z-0707-2021 was initiated by ICU Medical, Inc. on August 31, 2020 and is designated Class II. 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 me… The recall status is ongoing. Affected quantity: 88700.

Recall Details

Product Type
Devices
Report Date
December 30, 2020
Initiation Date
August 31, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
88700

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

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.

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.

Code Information

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

Other recalls by ICU Medical, Inc.

  • Z-2759-2026 Class II — Hotline Fluid Warming Set, single use device, is designed to warm blood and intr (June 24, 2026)
  • Z-2723-2026 Class II — ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) It (June 10, 2026)
  • Z-2724-2026 Class II — ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion (June 10, 2026)
  • Z-2311-2026 Class II — Plum Solo Precision IV Pump, 40001-0401 (April 29, 2026)
  • Z-2312-2026 Class II — Plum Duo Infusion Pump, 40002-0401 (April 29, 2026)
  • Z-2313-2026 Class II — Plum Duo Precision IV Pump, 40002-0403 (April 29, 2026)
  • Z-2210-2026 Class II — Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Cla (March 24, 2026)
  • Z-1100-2026 Class II — Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 (December 19, 2025)
  • Z-1111-2026 Class II — Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: (December 19, 2025)
  • Z-1101-2026 Class II — Portex Spinal Tray, Item No. A3729-24 A3595 (December 19, 2025)

FDA data resources