Medical device recalls Moderate risk

Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25…

Recall date
May 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2000-2025
FDA classification
Class II
Brand / firm
Becton Dickinson Infusion Therapy Systems, Inc.
Sold / distributed
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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly

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