FDAFDA · Food and drugs·Recall number Z-1983-2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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.
Published May 20, 2020 · Recall initiated: April 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Saline Flush Syringe compromised sterility due to holes in the packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Access Scientific LLC
- Distributor
- 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.
- Lot
- LOTS: 267011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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