POWERWAND XL 4Fr 8cm Maximum Barrier Kit recalled over labeling errors

Recall date

June 15, 2020

Source

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

Official notice title

Access Scientific LLC recalls POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD…

Recall number

Z-2550-2020

FDA classification

Class III

Brand / firm

Access Scientific LLC

Sold / distributed

US Nationwide distribution including in the state of NY.

Why it was recalled

Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.