# FDA recall Z-2617-2021

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2017-10-17.

## Product

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media.    Catalog Number: 60M701995

## Reason for recall

Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

## Distribution

Canada

## Key facts

- **Recall number:** Z-2617-2021
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-17
- **Report date:** 2021-10-06
- **Termination date:** 2022-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glens Falls, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2021

## Citation

> AI Analytics. FDA recall Z-2617-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-2617-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*