Device product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - 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.
Z-1977-2020
Product summary
- Event
- Event 85586
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,055 units
- Official record key
device-enforcement:Z-1977-2020
Official wording
Reason: Saline Flush Syringe compromised sterility due to holes in the packaging.
Code information: LOTS:259532, 259909, 260326, 269087, 267012, 269119, 269341
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
compromised sterility