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ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Recalled October 23, 2019 · FDA recall Z-0144-2020 · ICU Medical
Hazard
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. · FDA Class II
Units
6,516 units
Sold at
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.
Description
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Manufacturer(s)
ICU Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →