# FDA recall Z-2543-2021

> **Vascutek, Ltd.** · Class II · device recall initiated 2021-07-08.

## Product

The Instructions for Use (IFU) for:  Carotid Patch and Gelsoft Patch vascular patches.      FSN says Tapered Carotid Patch 920875t

## Reason for recall

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

## Distribution

Distribution was made to PR and Guam.

## Key facts

- **Recall number:** Z-2543-2021
- **Recalling firm:** Vascutek, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-08
- **Report date:** 2021-10-06
- **Termination date:** 2024-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Inchinnan, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2021

## Citation

> AI Analytics. FDA recall Z-2543-2021. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-2543-2021. Source: US FDA. Licensed CC0.

---

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