Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Recalled by Access Scientific LLC Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Access Scientific LLC directly.
Affected Products
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.
Quantity: 1710
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Access Scientific LLC
Access Scientific LLC has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report