Z-0400-2024 Class II Ongoing
FDA device recall Z-0400-2024 was initiated by Becton Dickinson Infusion Therapy Systems Inc. on October 4, 2023 and is designated Class II. Reason for recall: Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or … The recall status is ongoing. Affected quantity: 528,000.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 528,000
Product Description
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Reason for Recall
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
Distribution Pattern
US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.
Code Information
UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31