ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressur

Recalled October 23, 2019 · FDA recall Z-0126-2020 · 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

170,735 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 Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.

Manufacturer(s)

ICU Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →