medical Class III Updated 2020-07-22

Access Scientific LLC recalls POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 269939, 270552, 270874, and 272261.
View official government recall

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