FDAFDA · Food and drugs·Recall number Z-0131-2020
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 119 Inch. 1 unit per pouch; 50 pouches per case
Published October 23, 2019 · Recall initiated: July 29, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical Inc
- Distributor
- 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.
- Lot
- Product Code: 163630455, Lot number (UDI Number): 876175H (20887787007361, 10887787007364), 885385H (20887787007361, 10887787007364), 896995H (20887787007361, 10887787007364), 908235H (20887787007361, 10887787007364), 925755H (20887787007361, 10887787007364), 3843264 (20887787007361, 10887787007364)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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