Access Scientific LLC: Medical Device Recall in 2020 - (Recall #: Z-2550-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: June 15, 2020

Date Posted: July 22, 2020

Recall Number: Z-2550-2020

Event ID: 85808

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.

Status: Terminated

Product Quantity: 1710

Code Information:

Lot number 269939, 270552, 270874, and 272261.

Distribution Pattern:

US Nationwide distribution including in the state of NY.

Voluntary or Mandated:

Voluntary: Firm initiated