FDA recall Z-0400-2024

Becton Dickinson Infusion Therapy Systems Inc. · Class II · device

Product

BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2023-10-04
Report date
2023-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sandy, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2024