Z-0130-2020 Class II Terminated
FDA device recall Z-0130-2020 was initiated by ICU Medical Inc on July 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 January 12, 2024). Affected quantity: 45,900 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- July 29, 2019
- Termination Date
- January 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,900 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.