FDA-Device2018-08-15Class II
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
ICU Medical, Inc.
Hazard
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Sold states
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
Affected count
160,016 units total
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2018Don't want to check this manually?
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