# FDA recall Z-1467-2021

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2021-02-22.

## Product

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer   Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.

## Reason for recall

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

## Distribution

US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-1467-2021
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-22
- **Report date:** 2021-04-28
- **Termination date:** 2022-07-19

- **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-1467-2021

## Citation

> AI Analytics. FDA recall Z-1467-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1467-2021. Source: US FDA. Licensed CC0.

---

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