# FDA recall Z-2550-2020

> **Access Scientific LLC** · Class III · device recall initiated 2020-06-15.

## 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 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.

## Distribution

US Nationwide distribution including in the state of NY.

## Key facts

- **Recall number:** Z-2550-2020
- **Recalling firm:** Access Scientific LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-15
- **Report date:** 2020-07-22
- **Termination date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2020

## Citation

> AI Analytics. FDA recall Z-2550-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2550-2020. Source: US FDA. Licensed CC0.

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