# FDA recall Z-2237-2019

> **Santanello Surgical LLC** · Class II · device recall initiated 2019-06-10.

## Product

VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

## Reason for recall

Lack of package integrity may compromise sterility

## Distribution

FL,OK, OH, NY, ME, MN, WI

## Key facts

- **Recall number:** Z-2237-2019
- **Recalling firm:** Santanello Surgical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-10
- **Report date:** 2019-08-21
- **Termination date:** 2021-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2019

## Citation

> AI Analytics. FDA recall Z-2237-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2237-2019. Source: US FDA. Licensed CC0.

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