Recall Z-1979-2020 ยท FMF Syringe, Piston
Access Scientific LLC
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
| Date | May 14, 2020 (initiated Apr 23, 2020) |
| Status | Terminated |
| Reason | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Root cause | Packaging |
| Action | Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits. |
| Quantity | 570 units |
| Distribution | US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.