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Access Scientific LLC recalls POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD
Recalled July 22, 2020 · FDA recall Z-2550-2020 · Access Scientific
Hazard
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. · FDA Class III
Units
1710
Sold at
US Nationwide distribution including in the state of NY.
Description
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.
Product
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.
Manufacturer(s)
Access Scientific LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →