FDA-Device2021-09-01Class I
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Cardinal Health
Hazard
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Sold states
US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Affected count
267,217,860 eaches in total
Manufactured in
777 West St, N/A, Mansfield, MA, United States
Products
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2021Don't want to check this manually?
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