Z-0141-2020 Class II Terminated
FDA device recall Z-0141-2020 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: 32,416 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
- 32,416 units
Product Description
Reason for Recall
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0141-2020
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026