# FDA recall Z-2337-2018

> **Terumo Medical Corp** · Class II · device recall initiated 2018-04-09.

## Product

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

## Reason for recall

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

## Distribution

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

## Key facts

- **Recall number:** Z-2337-2018
- **Recalling firm:** Terumo Medical Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-09
- **Report date:** 2018-07-11
- **Termination date:** 2019-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2018

## Citation

> AI Analytics. FDA recall Z-2337-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2337-2018. Source: US FDA. Licensed CC0.

---

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