FDAFDA · Food and drugs·Recall number Z-0711-2021
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Published December 30, 2020 · Recall initiated: August 31, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- 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.
- Lot
- Lots: 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, 4909635 ,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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