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Recall Observatory FDA recall evidence

Device product

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Z-1999-2025

May 21, 2025

Class II

Product summary

Firm
Becton Dickinson Infusion Therapy Systems, Inc.
Event
Event 96865
Status
Ongoing
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-1999-2025

Official wording

Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information: Lot # 4229661/UDI: 382903814237

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.