Becton Dickinson Infusion Therapy Systems, Inc.: Device Recall
Recall #Z-2005-2025 · 05/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2005-2025
- 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: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/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.
Other Recalls by Becton Dickinson Infusion Therapy Systems, Inc.
- Class II: Risk 05/21/2025
- Class II: Risk 05/21/2025
- Class II: Risk 05/21/2025
- Class II: Risk 05/21/2025
- Class II: Risk 05/21/2025
View all recalls by Becton Dickinson Infusion Therapy Systems, Inc. →
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.