Becton Dickinson Infusion Therapy Systems, Inc.: Device Recall

Recall #Z-2001-2025 · 05/21/2025

Class II: Risk

Recall Details

Recall Number
Z-2001-2025
Classification
Class II
Product Type
Device
Recalling Firm
Becton Dickinson Infusion Therapy Systems, Inc.
Status
Ongoing
Date Initiated
05/21/2025
Location
Sandy, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 units

Reason for Recall

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

Product Description

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.