# FDA recall Z-1329-2021

> **Oscor, Inc.** · Class II · device recall initiated 2021-03-10.

## Product

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

## Reason for recall

Potential for open seal on sterile product

## Distribution

US Nationwide distribution in the state of New York.

## Key facts

- **Recall number:** Z-1329-2021
- **Recalling firm:** Oscor, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-10
- **Report date:** 2021-04-07
- **Termination date:** 2023-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palm Harbor, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2021

## Citation

> AI Analytics. FDA recall Z-1329-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1329-2021. Source: US FDA. Licensed CC0.

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