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Recall Observatory FDA recall evidence

Device product

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

Z-0400-2024

October 04, 2023

Class II

Product summary

Firm
Becton Dickinson Infusion Therapy Systems Inc.
Event
Event 93276
Status
Ongoing
Classification
Class II
Quantity
528,000
Official record key
device-enforcement:Z-0400-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.