# FDA recall Z-0253-2019

> **Custom Healthcare Systems, Inc.** · Class II · device recall initiated 2018-08-13.

## Product

CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY	  Product Number:	(1) ZZ-0956; (2)  ZZ-0685

## Reason for recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

## Distribution

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

## Key facts

- **Recall number:** Z-0253-2019
- **Recalling firm:** Custom Healthcare Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-13
- **Report date:** 2018-10-31
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0253-2019

## Citation

> AI Analytics. FDA recall Z-0253-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0253-2019. Source: US FDA. Licensed CC0.

---

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