Access Scientific LLC recalls BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/1085982100620…

Recall date

April 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1977-2020

FDA classification

Class II

Brand / firm

Access Scientific LLC

Sold / distributed

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.

Why it was recalled

Saline Flush Syringe compromised sterility due to holes in the packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.