Recall Z-0736-2024 ยท NGT Saline, Vascular Access Flush
Becton Dickinson & Company
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
| Date | Jan 17, 2024 (initiated Nov 16, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: Medical Device Product Advisory dated 11/16/23 was sent to customers. Please Take the Following Actions: 1. Immediately review your inventory for the affected product. a. If the product is used for syringe pumps, destroy all affected product subject to this field action following your institution's process for destruction. b. If the product is used for manual application, the product can continue to be used per IFU. 2. If the affected product was previously used on a patient, no further actions are needed. 3. If the affected product is currently in use with a syringe pump, replace |
| Quantity | 5,085,120 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton, Dickinson and Company, Feb 2, 2017 |