FDA-Device2023-12-06Class II
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Becton Dickinson Infusion Therapy Systems Inc.
Hazard
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
Sold states
US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.
Affected count
528,000
Manufactured in
9450 S State St, Sandy, UT, United States
Products
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2024Don't want to check this manually?
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