# FDA recall Z-0568-2021

> **Galt Medical Corporation** · Class II · device recall initiated 2020-11-16.

## Product

Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

## Reason for recall

Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

## Distribution

U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT.    O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE

## Key facts

- **Recall number:** Z-0568-2021
- **Recalling firm:** Galt Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-16
- **Report date:** 2020-12-23
- **Termination date:** 2022-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Garland, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2021

## Citation

> AI Analytics. FDA recall Z-0568-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0568-2021. Source: US FDA. Licensed CC0.

---

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