FDAFDA · Food and drugs·Recall number Z-0736-2024
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Published January 24, 2024 · Recall initiated: November 16, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Company
- Distributor
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX,UT, VA, WA, WI, WV.
- Lot
- UDI-DI: 30382903065470; Lot Numbers: 3207548 3207555 3214826 3226386 3214828 3226388 3250302 3250303 3250304
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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