Home / Recalls / ICU Medical Inc / Z-0138-2020

Z-0138-2020 Class II Terminated

Recalled by ICU Medical Inc — Lake Forest, IL

FDA device recall Z-0138-2020 was initiated by ICU Medical Inc on Jul 29, 2019 and is designated Class II. Reason for recall: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. The recall status is terminated (terminated Jan 12, 2024). Affected quantity: 6,400 units.

Recall Details

Product Type
Devices
Report Date
Oct 23, 2019
Initiation Date
Jul 29, 2019
Termination Date
Jan 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,400 units

Product Description

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

Reason for Recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Distribution Pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Code Information

Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163)

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0138-2020
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • Z-3163-2026 Class II — IV Sets with drip chambers (May 12, 2026)
  • Z-3158-2026 Class II — Oncology sets with drip chambers (May 12, 2026)
  • Z-3160-2026 Class II — IV Sets with drip chambers (May 12, 2026)
  • Z-3156-2026 Class II — Plum administration sets (May 12, 2026)
  • Z-3157-2026 Class II — IV Non-Dedicated Gravity Administration Sets with drip chambers (May 12, 2026)

FDA data resources