device · product 1 of 1
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
- Recall number
- Z-0736-2024
- Initiated
- November 16, 2023
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 5,085,120 units
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
UDI-DI: 30382903065470; Lot Numbers: 3207548 3207555 3214826 3226386 3214828 3226388 3250302 3250303 3250304
Distribution pattern
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.