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FDA (Device enforcement)Recalled 2023-11-16class ii

Becton Dickinson & Company: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 5,085,120 units Lot/code info: UDI-DI: 30382903065470; Lot Numbers: 3207548 3207555 3214826 3226386 3214828 3226388 3250302 3250303 3250304

UPC codes

30382903065470

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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