FDA recall Z-0699-2021

ICU Medical, Inc. · Class II · device

Product

42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Ch

Reason for recall

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.

Key facts

Status
Ongoing
Initiation date
2020-08-31
Report date
2020-12-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0699-2021