FDA-Device2014-03-19Class II

G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Smiths Medical ASD, Inc.
Hazard

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Sold states
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
Affected count
N/A
Manufactured in
10 Bowman Dr, N/A, Keene, NH, United States
Products
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2014

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