# FDA recall Z-2558-2018

> **Galt Medical Corporation** · Class II · device recall initiated 2018-05-02.

## Product

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36;     2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14;     3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07    4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

## Reason for recall

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

## Distribution

U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY,  NC, and Puerto Rico;    OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea

## Key facts

- **Recall number:** Z-2558-2018
- **Recalling firm:** Galt Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-08-08
- **Termination date:** 2020-07-20

- **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-2558-2018

## Citation

> AI Analytics. FDA recall Z-2558-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2558-2018. Source: US FDA. Licensed CC0.

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