Recall Z-2550-2020— Access Scientific LLC
Class III · Terminated
Class III FDA medical device recall by Access Scientific LLC, initiated 2020-06-15, terminated 2024-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Access Scientific LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-06-15
- Terminated
- 2024-10-30
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.