Z-2002-2025 Class II Ongoing
FDA device recall Z-2002-2025 was initiated by Becton Dickinson Infusion Therapy Systems, Inc. on May 21, 2025 and is designated Class II. Reason for recall: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. The recall status is ongoing. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Reason for Recall
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
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.
Code Information
Lot # 4290664/UDI:382903814336